Temu Product Safety and Compliance Policy

Temu is committed to providing consumers with safe, reliable, legal and compliant products. Sellers are prohibited from publishing or selling any illegal products, unsafe products, or products that pose a risk of causing personal injury or property damage on Temu. Sellers are responsible for ensuring that products listed and sold on Temu comply with all applicable laws and regulations, industry standards and safety standards, and all Temu policies related to those products, even if the product is not expressly described in our policies. Temu reserves the right to request additional information from sellers at any time to verify product safety and compliance, and reserves the right to remove any products it deems unsuitable for sale for any reason.

This policy applies to all sellers listing and selling products on Temu. If sellers list and sell products on Temu, please be sure to read this policy carefully.

This policy will be updated periodically, and it is the seller’s responsibility to refer to this page frequently.

Note: This policy is not legal advice, and is not intended to constitute legal advice. All information, content and materials provided below are for general reference only, with links included as additional information that may be useful, Temu does not guarantee the accuracy of any information provided in these links. Sellers are responsible for conducting the necessary investigations to ensure they fully understand and comply with all applicable product safety and compliance obligations. If sellers have any questions about product-related laws and regulations, please consult a professional legal advisor. Laws and regulations change frequently. This policy only reflects the public information and judgment at the time the policy is released. Sellers should regularly take note of changes in laws and regulations and take the appropriate actions.

I. Prohibited and Restricted Products

Temu is committed to working with sellers to help them better comply with product prohibitions and restrictions, and to prevent illegal, unsafe, and non-compliant goods from entering the Temu market. The following are some examples of prohibited and restricted products. These examples are not exhaustive, and may vary depending on the country/region where the products are listed or sold. Sellers are responsible for conducting the necessary research to ensure that they fully understand and comply with all applicable product prohibitions and restrictions. If sellers have any questions about product-related laws and regulations, please consult a professional legal advisor.

Note: The information, content, and materials provided below are not legal advice. They are for general reference only. The included links are provided solely as additional sources of information that may be useful. Temu does not guarantee the accuracy of any information contained in these links.

Products that Infringe Intellectual Property Rights

IMPORTANT: If sellers list and sell products on Temu, they must comply with all applicable laws, regulations, industry standards and safety standards, and all Temu policies related to those products, even if the product is not specifically described in our policies.

Temu respects and protects intellectual property rights, and resolutely resists any counterfeiting, piracy, illegal copying, fraud and other illegal activities and behaviors that infringe on the interests of consumers and the intellectual property rights of third parties. Sellers are prohibited from publishing or selling any counterfeit or shoddy goods on Temu. Temu has developed a comprehensive policy for this purpose. This section briefly describes some of the intellectual property issues that may arise when sellers list and sell products on Temu. For more information, please refer to the Temu Intellectual Property Policy.

Examples of prohibited sales:

Imitating genuine brand features in an attempt to pass off as genuine brands.
Product information containing the words "imitation", "fake", "knockoff", or similar.
Unauthorized audio, video, or copyrighted content.

For example: electronic products with pre-installed unauthorized audio, video, or copyrighted content.

Other products involving intellectual property infringement.

Discriminatory and Offensive Products

IMPORTANT: If sellers list and sell products on Temu, they must comply with all applicable laws, regulations, industry standards and safety standards, as well as all Temu policies related to these products, even if the product is not explicitly described in our policies.

Temu encourages trust and respect, pays close attention to the cultural differences and sensitive issues among global consumer groups, and strives to create a good trading environment. Temu prohibits the posting or sale of products that contain discriminatory and offensive content.

Examples of prohibited sales:

Discrimination, profanity, denigration, insult, or hostility based on race, ethnicity, religion, nationality, tribe, identity, age, skin color, gender, sexual orientation, gender identity, disability, serious illness, etc.
Promotion, support, praise, incitement or glorification of Nazism, racism, imperialism, extremism, terrorist organizations, aggressive wars, violent conflicts, hate crimes, criminal acts, illegal activities, etc.
Exploitation of and profit from human disasters and natural disasters.
Promotion or glorification of harassment, intimidation, exploitation, bullying of others, and threats of physical or mental harm to others.
Promotion or glorification of suicide.
Child abuse and exploitation.
Human trafficking and smuggling.
Disturbing descriptions of blood, horror or violence.

Inappropriate Pornographic Products

IMPORTANT: If sellers list and sell products on Temu, they must comply with all applicable laws, regulations, industry standards, and safety standards, as well as all Temu policies related to these products, even if the product is not explicitly described in our policies.

Temu prohibits the posting or sale of products containing pornographic or inappropriate content.

If sellers list and sell Permitted Products, such as adult products, on Temu, they must comply with all applicable laws, regulations, industry standards, and safety standards, as well as all Temu policies related to those products, including (but not limited to) complying with applicable regional sales restrictions and implementing age restriction labeling and age verification procedures as required by relevant laws and regulations.

Examples of prohibited sales:

Content or information related to pornography involving minors, non-consensual or paid sex, or other illegal sexual themes.

For example: child sex dolls, pedophilia, rape, incest, bestiality, necrophilia, etc.

Second-hand underwear (or 'pre-worn unwashed underwear') and similar products.
Display of genitals, vaginal or anal insertion, vaginal, oral, anal sex, masturbation, bodily fluids from sexual intercourse, etc.
Pornographic content in the form of cartoons or comics.
Pornographic and obscene language.

Examples of regional sales restrictions:

Sex dolls.
Male or female masturbators.
Bondage equipment.
Sex toys.
Erotic clothing.
Erotic furniture.
Adult novelties.
Sex game supplies.

Gambling-related Products

IMPORTANT: If sellers list and sell products on Temu, they must comply with all applicable laws, regulations, industry standards, and safety standards, as well as all Temu policies related to those products, even if the product is not specifically described in our policies.

Temu supports and complies with the laws, regulations, and industry standards regarding gambling in various countries and regions, and prohibits the release or sale of gambling-related products.

Examples of prohibited sales:

Offline gambling.
Online gambling.
Social casinos.
Bingo.
Lottery.
Sports predictions and betting.
Gambling tools such as slot machines, roulette, chips for gambling, electronic gaming machines for gambling.
Product listings that claim or imply the ability to make money, get high returns, get gambling bonuses, etc.

Alcohol-related Products

IMPORTANT: If sellers list and sell products on Temu, they must comply with all applicable laws, regulations, industry standards, and safety standards, as well as all Temu policies related to those products, even if the product is not explicitly described in our policies.

Temu prohibits the posting or sale of alcohol and alcoholic beverages, and prohibits the posting or sale of products with inappropriate content involving alcohol and alcoholic beverages.

If sellers list and sell Permitted Products related to alcohol and alcoholic beverages on Temu, they must comply with all applicable laws, regulations, industry and safety standards, and all Temu policies related to those products, including (but not limited to) compliance with applicable regional sales restrictions and age restriction labeling and age verification procedures as required by applicable laws and regulations.

Examples of prohibited sales:

Liquor (e.g. wine, beer) and alcoholic beverages
Liquor licenses

Example of regional sales restrictions:

Equipment for producing alcohol and alcoholic beverages, such as alcohol distillation kits.

Examples of prohibited inappropriate content:

Products that encourage or imply drinking under the legal age.
Products that encourage or imply excessive drinking, or that show binge drinking or drinking competitions.
Products that imply that drinking can help improve social status, sexual ability, workplace prestige, intelligence, or athletic ability.
Products that imply that drinking has health benefits or produces medical effects.

Tobacco-related Products

IMPORTANT: If sellers list and sell products on Temu, they must comply with all applicable laws, regulations, industry standards, and safety standards, as well as all Temu policies related to those products, even if the product is not specifically described in our policies.

Temu prohibits the listing or sale of tobacco and products containing tobacco.

If sellers list and sell Tobacco-Related Permitted Products on Temu, they must comply with all applicable laws, regulations, industry and safety standards, and all Temu policies related to those products, including (but not limited to) compliance with applicable regional sales restrictions and age restriction labeling and age verification procedures as required by applicable laws and regulations.

Examples of prohibited sales:

Tobacco and products containing tobacco.

For example: cigarettes, cigars, tobacco gels, smokeless tobacco (such as chewing tobacco, dipping tobacco, snuff, dissolvable tobacco, etc.).

Nicotine inhalers and nicotine nasal sprays.
Smoking cessation products that do not comply with applicable laws and regulations and are not properly licensed or approved.

Examples of regional sales restrictions:

E-cigarettes and related products (with or without nicotine), including but not limited to:

E-cigarettes.
E-hookahs.
E-cigars.
E-cigarette accessories, such as atomizers, batteries, cartridges, e-liquids or similar refills.

Herbal tobacco.
Hookahs.
Flavored tobacco and related products.
Cigarette rolling devices.
Products displaying tobacco brands or logos.

Currency and Finance related Products

IMPORTANT: If sellers list and sell products on Temu, they must comply with all applicable laws, regulations, industry standards, and safety standards, as well as all Temu policies related to those products, even if the product is not specifically described in our policies.

Temu prohibits the release or sale of legal tender and any non-standard props and counterfeit currencies, and prohibits the release or sale of products involving the manufacture and counterfeiting of legal tender.

If sellers list and sell prop currency, counterfeit currency and other permitted products on Temu, they must comply with all applicable laws, regulations, industry standards, and safety standards, as well as all Temu policies related to these products, including (but not limited to) complying with applicable regional sales restrictions and meeting the marking requirements for prop currency and counterfeit currency in relevant laws and regulations.

Examples of prohibited sales:

Legal tender, including currency that is deemed to be legal tender, including banknotes and coins.
Irregular prop money and counterfeit money that does not comply with applicable laws and regulations.
Prop money and counterfeit money that may be considered by humans or machines to have the nature of legal tender or circulation.
Changes to legal tender for purposes other than currency protection, such as holographic, edging, spraying, electroplating or coloring.
Defacement, defilement, defamation, tarnishing or distortion of the image of people, buildings, etc. on legal tender.
Cryptocurrency and virtual currency, mining equipment, mining tutorials and software.
Financial instruments, such as bills of exchange, checks, gold certificates, silver certificates, stocks, and securities.
Gift cards, coupons, and electronic redemption codes.
Government subsidies and benefits.
Products involving financial services such as insurance, loans, remittances, and wealth management.
Products with financial transaction functions such as POS machines, card readers, and credit card readers.
Equipment and content used to create counterfeit goods, such as printing machines, printing paper, printing ink, and printing tutorials.
Goods that may facilitate money laundering.

Precious Metals, Gems, and Jewelry

Temu prohibits the listing or sale of non-compliant precious metals, jewelry, and accessories.

If sellers list and sell precious metals, gems, and jewelry on Temu, they must comply with all applicable laws, regulations, industry standards, and safety standards, as well as all Temu policies related to these products, including (but not limited to) complying with applicable regional sales restrictions, adding the necessary markings as required by relevant laws and regulations, and complying with the requirements of relevant laws and regulations regarding the use of prohibited and restricted substances.

Examples of prohibited sales:

Failure to add necessary markings as required by applicable laws and regulations.
Non-compliance with applicable laws and regulations regarding prohibited and restricted substances.

For example: non-compliance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

Natural diamonds that do not comply with the Kimberley Process Certification Scheme.
Irradiated gemstones without proper authorization.

For example: improper authorization from the US Nuclear Regulatory Commission (NRC) (US market).

Glass-filled gemstones.
Gemstones for which authenticity cannot be confirmed.
Products that may facilitate money laundering.
Products that involve false or misleading advertising.

For example: non-compliance with the US Federal Trade Commission (FTC) "Guides for the Jewelry, Precious Metals, and Pewter Industries" (US market).

Stamp-related Products

IMPORTANT: If sellers list and sell products on Temu, they must comply with all applicable laws and regulations, industry standards, and safety standards, as well as all Temu policies related to these products, even if the product is not explicitly described in our policies.

Temu prohibits the release or sale of counterfeit stamps, and prohibits the release or sale of products involving content related to stamp manufacturing and counterfeiting.

If sellers list and sell Permitted Products such as imitation stamps on Temu, they must comply with all applicable laws, regulations, industry and safety standards, and all Temu policies related to those products, including (but not limited to) complying with applicable regional sales restrictions and marking requirements for imitation stamps in relevant laws and regulations.

Examples of prohibited sales:

Counterfeit postage stamps.
Postage meters.
Equipment and contents used in stamp manufacturing, counterfeiting.
USPS US Flag Forever stamps.
Items that may facilitate money laundering.

Human Body Parts, Remains, and Funerary Objects

IMPORTANT: Sellers who list and sell items on Temu must comply with all applicable laws, regulations, industry and safety standards, as well as all Temu policies related to those items, even if the item is not specifically described in our policies.

Temu prohibits the listing or sale of human body parts, remains, and funerary objects.

If sellers list and sell Permitted Products such as human hair wigs on Temu, they must comply with all applicable laws, regulations, industry and safety standards, as well as all Temu policies related to those products, including (but not limited to) compliance with internationally recognized human rights principles, for which Temu has a comprehensive policy. Please refer to the Temu Third Party Code of Conduct for more information.

Examples of prohibited sales:

Human body parts.

For example: organs, tissue, bone, blood, eggs, sperm, fertilized eggs, and embryos.

Human remains.
Human excreta and body fluids.
Funerary objects.

For example: aboriginal funerary objects.

Historical gravestones.
Archaeological discoveries.

Illegal Items

IMPORTANT: Sellers who list and sell products on Temu must comply with all applicable laws, regulations, industry and safety standards, as well as all Temu policies related to those products, even if the product is not specifically described in our policies.

Temu prohibits the posting or sale of illegal goods for illegal purposes, the manufacture of illegal goods, and the conduct of illegal activities and behaviors.

Examples of prohibited sales:

Products used for illegal theft.

For example: master keys, strip lock picking tools, tubular lock picking tools, motor vehicle master keys, key duplication equipment, training locks, lock repair equipment, shoplifting equipment, card reading equipment, wireless key programming equipment, password grabbing equipment.

Products used for illegal surveillance.

For example: cameras, telescopes, and eavesdropping devices used for illegal purposes such as harassment, voyeurism, espionage, and sexual crimes.

Products used for illegal descrambling, intrusion, interference, and interception, as well as infringing goods.

For example: hacking tools, signal jammers, or jamming equipment for laser speedometers, equipment used to change the readings of metering devices such as electricity meters, equipment used to change car odometers, illegal descrambling and intrusion equipment for cable and satellite TV, unauthorized set-top boxes that provide free access to digital content, mobile phone unlocking devices, DVD duplicators that circumvent copyright protection, Blu-ray players with region codes removed, products with deleted or altered serial numbers, unauthorized free software, keyloggers, EAN code generators, or Flipper Zero gadgets.

Products used for illegal telecommunications.

For example: devices for bulk insertion of phone cards, devices for changing caller IDs, virtual dialing software, devices for telecommunications network fraud.

Products used for suicide or assisting others in committing suicide.
Products that violate privacy or confidential information.
Products obtained illegally.
Other illegal products used for illegal purposes, manufacturing illegal products, or engaging in illegal activities and behaviors.

Prohibited Product Notice

IMPORTANT: If sellers list and sell products on Temu, they must comply with all applicable laws, regulations, industry standards and safety standards, as well as all Temu policies related to those products, even if the product is not explicitly described in our policies.

Temu prohibits unfair or deceptive merchandising claims. Sellers are responsible for ensuring that any descriptions they provide for goods are true, accurate, and reliable, and do not mislead about the quality and characteristics of the goods. Note that false descriptions are just as misleading as partially correct descriptions because they fail to disclose facts of which the consumer should be aware.

Common descriptions of the quality and characteristics of a product include: origin, manufacturing conditions and status, quality, warranty, guarantee, material, value, applicable scenarios, etc. Sellers should review applicable laws and regulations, industry codes, and guidance documents to ensure that the claims made for their products fully comply with the requirements.

Examples of prohibited product claims:

Misleading disease claims

For example: Unless an exemption applies, a product listing that claims to treat, prevent or cure a condition or illness listed in Schedule A and Section 3 to the Food and Drugs Act (Canadian market).

Misleading environmental claims

For example: An environmental claim in a product listing does not comply with the requirements of the US Federal Trade Commission (FTC) Guides for the Use of Environmental Marketing Claims (US market).

Misleading pesticide claims

For example: A pesticide treatment product that is not registered with the US Environmental Protection Agency (EPA) makes a public health claim, such as “fights bacteria, provides antimicrobial protection or controls fungi” (US market).

Misleading licensing, approval, certification or authorization claims.

For example:

The US Consumer Product Safety Commission (CPSC) does not certify or approve products; therefore, product listings should not claim or imply that the CPSC has certified or approved products.
Health Canada does not approve or endorse products; therefore, product listings should not claim or imply that Health Canada has approved or endorsed products.
Product listings should not use the US Food and Drug Administration (FDA) FDA logo. For more information, see Is It Really ‘FDA-Approved’? and FDA Name and Logo Policy.

Government and Military Products

IMPORTANT: If sellers list and sell products on Temu, they must comply with all applicable laws, regulations, industry standards, and safety standards, as well as all Temu policies related to these products, even if the product is not specifically described in our policies.

Temu prohibits the posting or sale of government and military and police supplies, and prohibits the posting or sale of products that are used to imitate government and military and police supplies.

Examples of prohibited sales:

Military products and their imitations.

For example: military uniforms, rank insignia, ballistic plates, bulletproof helmets, bulletproof vests, military gas masks.

Police products and their imitations.

For example: police uniforms, rank insignia, riot shields, handcuffs, batons, or police lights.

Government supplies and their imitations.

For example: products containing the seals of the President, Vice President, Senate, House of Representatives, or Congress.

Government-issued certificates or documents and their imitations.

For example: birth certificates, ID cards, driver's licenses, or permits.

Products that pretend to be government and military and police supplies.
Products intended for law enforcement use only.

Firearms, Ammunition, Explosives, Weapons, and related Products

IMPORTANT: If sellers list and sell products on Temu, they must comply with all applicable laws, regulations, industry standards and safety standards, as well as all Temu policies related to these products, even if the product is not explicitly described in our policies.

Temu prohibits the listing or sale of firearms, ammunition, explosives, weapons, and other products that are offensive or endanger the personal safety of others.

If sellers list and sell Permitted Products such as toy guns and Permitted Knives on Temu, they must comply with all applicable laws, regulations, industry and safety standards, and all Temu policies related to these products, including (but not limited to) complying with applicable regional sales restrictions, obtaining all necessary licenses and approvals, and conducting age restriction labeling and age verification procedures as required by relevant laws and regulations.

Examples of prohibited sales:

Firearms and replica firearms.

Examples include: pistols, rifles, submachine guns, machine guns, shotguns, black powder guns, automatic guns, sporting guns, hunting guns, muzzle-loading guns, tranquilizer guns, riot guns, modified guns, solenoid guns, electronic guns, improvised guns, 3D printed guns, any form of camouflage guns, antique and collectible guns, signal guns, starter guns, flare launchers.

Toy guns and replica firearms without required markings

For example: those that do not comply with the marking requirements for toy guns and replica firearms in Title 15 Code of Federal Regulations (CFR) Part 272 (US market).

Accessories (internal and external) of firearms and replica firearms.

For example: bump stocks, non-fixed stocks, grips and grip accessories, telescoping stocks and weapon kits, threaded barrels and adapters, magazines and related items, conversion devices/conversion kits, special tools for assault weapons and automatic rifles, gun frames, automatic sears, barrels, multi-rail devices, muzzle brakes, receivers, silencers, suppressors, homemade silencers and silencer-like devices, all internal and moving firearm parts (such as firing pins, springs, stops, bolt catches, guide rods, bolt carriers, bolt pins, buffer pins, buffer tubes, telescoping tubes, counter pins), machinery for the production of firearms.

Ammunition and ammunition parts.

For example: black powder, blank shells, bullets, bullet heads, cartridge cases, fuses.

Certain knives.

For example: automatic knives, automatic folding knives, switchblades, spring-powered knives, spring-assisted knives, spring-button knives, ballistic tactical knives, ballistic knives, gravity knives, gravity-assisted knives, butterfly knives, inertia knives, knuckle knives, knives disguised as harmless objects (such as lipstick knives, writing pen knives, comb knives, belt buckle knives, bracelet knives, bank card knives, key knives, lighter knives), invisible knives, hand daggers, slashing knives, swords, concealed swords, bayonets, throwing knives, darts, throwing axes, machetes, zombie knives, fidget spinner knives.

Weapons.

For example: tasers, pepper sprays, sling sticks, heavy sticks, wooden sticks, oriental sticks, bamboo sticks, nunchakus, lead canes, rattan sticks, police batons, police batons, police canes, bludgeons, steel sticks, blackjacks, spears, long guns, maces, ronin forks, dart guns, blowpipes, blow guns, flying needles, dart fingertip spinners, crossbows, cool sticks, brass knuckles, meteor hammers, metal ball flails, lock copper, strangulation wire, strangulation chain.

Explosives and related products.

For example: fireworks, flares, grenades, mines, grenade launchers, improvised explosive devices, explosive fuses, explosives and explosive precursors, explosives production tutorials.

Instruments of torture and tools to restrict freedom.
Other offensive instruments or those that may be used to endanger the personal safety of others.

Examples of regional sales restrictions:

Guns that do not contain gunpowder, such as air guns, airsoft guns, BB guns, paintball guns, etc.
Holsters, gun cleaning tools.
Targeting tools.
Bows and arrows.
Crossbows.
Harpoons.
Slingshots, catapults.
Knives, such as folding knives, utility knives, garden knives, kitchen knives, etc.

For example: In the UK, under the Offensive Weapons Act 2019, the sale of bladed items to persons under the age of 18 and the delivery of bladed products to residential premises are prohibited. For more information, see the UK Government guidance documents.

Animal and Plant-related Products

Temu prohibits the posting or sale of endangered and protected animal and plant products, illegal animal and plant products, harmful animal and plant products, and products used to abuse animals or that contain animal abuse content.

If sellers list and sell Permitted Plant and Animal Products on Temu, they must comply with all applicable laws, regulations, industry and safety standards, and all Temu policies related to those Products, including (but not limited to) complying with applicable regional sales restrictions (for example, many US state regulations have additional requirements for shipping and labeling), obtaining all necessary licenses and approvals, and meeting biosafety requirements.

Examples of prohibited sales:

Live animals.
Animal feces.
Live cats, dogs, and their parts.
Ivory and its products.
Endangered and protected animal and plant products.

For example: endangered and protected animals and plants as defined by the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES).

Illegal animal and plant products.
Animal and plant products that are dangerous or potentially lethal to handle or consume.
Animal and plant products designated as "pests" by national governments.
Animal and plant products subject to quarantine or other biosecurity controls by national governments.
Products that have undergone ear cropping, tail docking, declawing, or any other removal or modification of companion animals.
Traps for endangered and protected animals.
Steel-jaw animal traps.

Examples of regional sales restrictions:

Animal fur and fur products.
Glue traps for vertebrates and rodents.
Electric shock, animal training collars and equipment with inward-pointing spikes.
Bird nets.
Fishing nets and other fishing gear.

Vehicle-related Products

Temu prohibits the listing or sale of unsafe and non-compliant vehicle-related products.

If sellers list or sell Permitted Vehicle-related Products on Temu, they must comply with all applicable laws, regulations, industry and safety standards, and all Temu policies related to those Products, including (but not limited to) complying with applicable regional sales restrictions, obtaining all necessary licenses and approvals, complying with relevant laws and regulations regarding vehicle safety and air pollution prevention, and carrying markings (such as DOT and ECE marks) where applicable. Sellers selling goods such as batteries or tires may have additional obligations.

Examples of prohibited sales:

Used tires, wheels, wheel accessories.
Automotive airbags, airbag covers, airbag inflators, airbag components.
Products used to interfere with the normal operation of an engine’s emission control system.

For example: deletion kits for exhaust gas recirculation (EGR), diesel particulate filter (DPF) or selective catalyst reduction (SCR), throttle deletion kits.

Products used to circumvent driver assistance systems or other automotive safety features.

For example: steering wheel weight rings, seat belt warning silencers.

Products used to obstruct law enforcement, vehicle or road safety features, or other legal requirements.

For example: license plate anti-slap spray or covers, police radar jammers, devices for changing a car’s odometer.

Vehicle Identification Number (VIN) tags.
All-fabric car seats.

Examples of regional sales restrictions:

Automotive seat belts, seat belt assemblies.
Wheel weights containing lead.
High intensity discharge (HID) conversion kits.
Light emitting diode (LED) headlight conversion kits.

Electrical and Electronic Products

IMPORTANT: If sellers list and sell products on Temu, they must comply with all applicable laws, regulations, industry standards. and safety standards, as well as all Temu policies related to those products, even if the product is not specifically described in our policies.

Temu prohibits the release or sale of unsafe and non-compliant electrical and electronic products.

If sellers list and sell approved electrical and electronic products on Temu, they must comply with all applicable laws, regulations, industry and safety standards, and all Temu policies related to these products, including (but not limited to) complying with applicable regional sales restrictions, obtaining all necessary licenses and approvals, complying with relevant laws and regulations on electrical safety, wireless interference, and energy efficiency labeling, not circumventing other technical controls (such as copyright protection), and carrying markings (such as CE marking) where applicable. Sellers selling items such as batteries or video display devices may have additional obligations.

Examples of prohibited sales:

Products that use military frequencies.
Products that pose a risk of explosion.
Internet-enabled products with security vulnerabilities.
Products used for infringing or unauthorized access to digital media or other protected content.
USB-C (or USB Type-C) cables or adapters that do not comply with the standard specifications published by USB Implementers Forum Inc.
Laser pointers that do not comply with applicable laws and regulations.

For example: Swiss Decree No. 814.711 on the Federal Regulation for Protection against Risks of Non-ionizing Radiation and Sound (O-NIRSA) prohibits the import, transit, provision, supply, and possession of Class 1M, 2, 2M, 3R, 3B and 4 laser pointers (Swiss market).

Examples of regional sales restrictions:

Hand-held hair dryers without immersion protection plugs (US market).
Hand-held electronic devices intended for contact electric shock.
Portable ultraviolet devices.
Discharge graining equipment.
Radar detectors.
Signal boosters and power amplifiers.
Radio transceiver equipment.
Drones.
Incandescent and halogen lamps.

Cosmetics

Temu prohibits the release or sale of unsafe and non-compliant cosmetics. Cosmetics must be safe to use and must not pose any unreasonable risk of injury or illness.

If sellers list and sell Permitted Cosmetics on Temu, they must comply with all applicable laws, regulations, industry and safety standards, and all Temu policies related to those products, including (but not limited to) complying with applicable regional sales restrictions, complying with relevant laws and regulations regarding cosmetic safety or prohibited and restricted substances, and being properly packaged and including any required labels and warnings.

Examples of prohibited sales:

Products that require a prescription or that require supervision or direction from a healthcare professional.
Products intended for professional use.
Products that contain prohibited ingredients or ingredients that do not meet restrictions.

For example: skin creams containing mercury, eyelash and eyebrow products containing bimatoprost, or eye makeup containing Kohl. For more information, see the laws and regulations on cosmetics in each country/region.

Products labeled "Test product", "Not for sale", "No resale" or similar, and not manufactured for official sale purposes.
Products that have been opened or used.
Products that have expired or have a shelf life.
Products that are adulterated or mixed with inferior products.
Products that are not properly labeled or packaged.
Products that have been altered in terms of container, packaging, performance, safety specifications, or instructions for use.
Products described as food grade or edible.
Products that have been tested on animals or that contain ingredients that have been tested on animals.
Rinse-off cosmetics that contain plastic microparticles.
Fragrances that imitate or attempt to reproduce the scent of branded fragrances.

Examples of regional sales restrictions:

Teeth whitening products containing peroxides.

For example: teeth whitening products that contain or release more than 0.1% hydrogen peroxide (EU and UK markets).

Oral products containing fluoride.
Products containing minoxidil.
Products containing nanomaterials.
Products containing snake oil.
Tattoo inks and tattoo stickers.

For example: products that do not comply with the requirements of Regulation (EU) 2020/2081 on substances in tattoo inks or permanent cosmetics (EU market).

Products that make animal testing-free claims.

Food and Dietary Supplements

IMPORTANT: If sellers list and sell products on Temu, they must comply with all applicable laws, regulations, industry standards and safety standards, and all Temu policies related to those products, even if the product is not specifically described in our policies.

Temu prohibits the release or sale of unsafe and non-compliant foods and dietary supplements, and any foods and dietary supplements sold must not present any unreasonable risk of injury or illness.

If sellers list and sell permitted foods and dietary supplements on Temu, they must comply with all applicable laws, regulations, industry and safety standards, and all Temu policies related to these products, including (but not limited to) complying with applicable regional sales restrictions, obtaining all necessary licenses and approvals, complying with relevant laws and regulations regarding food and biosafety or prohibited and restricted substances, and being properly packaged and including any required labels and warnings.

Food types such as food for infant and young children, foods of animal origin, novel foods, pet or animal foods, and dietary supplements may have specific rules and requirements that businesses must comply with.

Examples of prohibited sales:

Products that require supervision or guidance from a healthcare professional, or products that can only be sold in pharmacies.
Products for special medical purposes.
Products that contain prohibited ingredients or contain ingredients that do not meet restrictions.

For example: betel nut, poppy seeds, hallucinogenic honey, melamine. For more information, see the laws and regulations of each country regarding food and dietary supplements.

Products that are unfit for human or animal consumption.
Products that consist, in whole or in part, of any filthy, spoiled, disgusting, stinking, decayed, or diseased animal or plant matter.
Products that have been manufactured, prepared, preserved, packaged, or stored under unsanitary conditions.
Products that are marked "Test", "Not for sale", "Not for resale", or similar and are not manufactured for official sale.
Products that have been opened or used.
Products that have expired or have a shelf life.
Products that are adulterated or contain inferior products.
Products that are improperly labeled or packaged.
Products that have been altered in terms of container, packaging, performance, safety specifications, or directions for use.
Products that claim or imply the same effects as controlled substances or prescription drugs.
Fitness supplements that contain methylhexanamine, steroids, dinitrophenol, prostaglandins, methyltestosterone, or any other undeclared substance or prohibited ingredient.
Sexual performance supplements containing Viagra, sildenafil, lovastatin, tadalafil, phentolamine, sulfonafil, aminotadalafil, or any other undeclared substances or banned ingredients.
Weight loss supplements containing sibutramine, ephedra, phenolphthalein, or any other undeclared substances or banned ingredients.

Pharmaceutical products

IMPORTANT: If sellers list and sell products on Temu, they must comply with all applicable laws, regulations, industry standards, and safety standards, as well as all Temu policies related to these products, even if the product is not explicitly described in our policies.

Temu prohibits the release or sale of unsafe and non-compliant drugs, and any drugs listed must not pose any unreasonable risk of causing injury or illness.

If sellers list and sell approved pharmaceuticals and related products on Temu, they must comply with all applicable laws, regulations, industry standards, and safety standards, as well as all Temu policies related to these products, including (but not limited to) complying with applicable regional sales restrictions, obtaining all necessary licenses and approvals, complying with relevant laws and regulations regarding pharmaceutical safety or prohibited and restricted substances, and must be properly packaged and include any necessary labels and warnings.

Examples of prohibited sales:

Illegal drugs, drugs and substances that require a prescription or the supervision or direction of a healthcare professional, controlled substances, substances that require special licenses and approvals.

Examples: cocaine, heroin, ecstasy, amphetamines, phencyclidine, alfentanil, methadone, morphine, opium, poppy seeds, marijuana, ephedrine, pseudoephedrine, antibiotics, growth hormone, human chorionic gonadotropin, melatonin, thyroid or adrenal extracts, adrenal hormone dehydroepiandrosterone, steroids.

Equipment used to make, use, or conceal the above drugs and substances.

Examples: marijuana leaf cutters, tablet presses, pill presses, capsule fillers, pill binders and excipients, distillation extraction tools, purity test reagents, atomizers, and related accessories.

Products designed to pass drug tests, such as urine additives and synthetic urine.
Human and animal vaccines.
Products marked "Testing material", "Not for sale", "Not for resale", or similar, and not manufactured for official sale purposes.
Products that are opened or used.
Products past their expiration date or shelf life.
Products that are adulterated or substandard.
Products that are improperly labeled or packaged.
Products with altered containers, packaging, properties, safety specifications, or directions for use.
Research peptides and research chemicals.
Products claiming to cure cancer.
Parasite cleansers, parasite detoxifiers, and similar products.
Detox mud baths, chelation therapy products, Miracle Mineral Solution (MMS), and similar products that are misleading or that pose a health risk.
Toxic herbs.

For example: arsenic, mercury (mercury).

Medical Devices

IMPORTANT: Sellers listing and selling products on Temu must comply with all applicable laws, regulations, industry and safety standards, as well as all Temu policies related to those products, even if the product is not specifically described in our policies.

Temu prohibits the release or sale of unsafe and non-compliant medical devices, and all medical devices must not pose any unreasonable risk of causing injury or illness.

If sellers list and sell approved medical devices on Temu, they must comply with all applicable laws, regulations, industry standards, and safety standards, as well as all Temu policies related to these products, including (but not limited to) complying with applicable regional sales restrictions, obtaining all necessary licenses and approvals, complying with relevant laws and regulations on the safety and performance requirements of medical devices, and properly packaging the products and including any necessary labels and warnings.

Examples of prohibited sales:

Products that require a prescription or supervision or direction from a healthcare professional.
Products for professional use.
Products labeled "Test", "Not for sale", "Not for resale", or similar, and that are not manufactured for formal sale purposes.
Products that have been opened or used.
Products that have expired or have a shelf life.
Products that are adulterated or contain inferior products.
Products that are not properly labeled or packaged.
Products that have been altered in terms of their container, packaging, performance, safety specifications, or directions for use.
Human and medical implants.
Products that claim to predict the sex of an unborn baby.
Products that are intended to restrict the movement of people with disabilities, dementia, or other medical conditions.
DNA tests or paternity tests.

Examples of regional sales restrictions:

Products that use ultrasound technology for wrinkle removal and/or body contouring (US market).
Non-invasive blood glucose monitoring devices (US market).
Reading glasses and contact lenses.

Consumer Chemicals such as Pesticides and Fertilizers

Temu prohibits the release or sale of unsafe and non-compliant pesticides, fertilizers and other consumer chemicals.

If sellers list and sell permitted consumer chemicals on Temu, they must comply with all applicable laws, regulations, industry and safety standards, and all Temu policies related to those products, including (but not limited to) complying with applicable regional sales restrictions, obtaining all necessary licenses and approvals, complying with relevant laws and regulations regarding health, physical and environmental hazards, proper packaging, and any required labels and warnings.

Examples of prohibited sales:

Products for professional or commercial use, not for sale to general consumers, such as cleaners for professional use.
Products that have been opened or used.
Products that have expired or have a shelf life.
Products that are adulterated or mixed with inferior products.
Products that are not properly labeled or packaged.
Products that have been altered in terms of container, packaging, performance, safety specifications or instructions for use.
Illegal pesticides and banned pesticides.

For example: illegal naphthalene moth repellent products, insecticidal chalk, aldicarb, dichlorvos, monocrotophos, chlordane.

Chlorine dioxide-based space disinfection cards that claim to provide wearers with protection against the coronavirus.
Sodium nitrate.
Sodium nitrite.
Sodium azide.
Hydrofluoric acid.
Ethanolamine.
Carbon tetrachloride and its mixtures.
Products containing cyanide.
Products containing bisphenol A.
Products containing asbestos.
Products containing polychlorinated biphenyls.
Products containing nitrous oxide.
Certain products containing PFAS (per- and polyfluoroalkyl substances).
Liquid mercury and mercury-containing products.

Examples include: thermometers, thermostats, batteries, switches, wheel weights containing mercury.

Radioactive materials or products contaminated by radiation.

For example: energy signs based on quantum science, which often promote the ability to maintain health, balance energy, improve mood, and protect people from electromagnetic fields.

Explosives and products that can be used as explosive precursors.

For example: nitric acid, nitromethane, ammonium nitrate, potassium chlorate, potassium perchlorate, hexamethylenetetramine, potassium nitrate, sodium nitrate, calcium ammonium nitrate, magnesium nitrate hexahydrate.

Persistent organic pollutants.

For example: regulated substances listed in the Stockholm Convention.

Substances that deplete the ozone layer.

For example: regulated substances listed in The Montreal Protocol on Substances that Deplete the Ozone Layer and The Vienna Convention for the Protection of the Ozone Layer.

Other products that may involve health, physical and environmental hazards, and that are prohibited or do not meet restrictions.

For example: Controlled substances listed in the Rotterdam Convention and the Chemical Weapons Convention.

Other Prohibited Products

Temu prohibits the listing or sale of unsafe and non-compliant goods. For various reasons including compliance with laws and regulations, product safety, consumer experience, and so on, we may restrict sellers from selling certain types of goods.

Examples of prohibited sales:

Padded crib bumpers.
Baby inclined sleep products.
Elephant sleep pillows.
Baby sleep positioning products.
Side cribs.
Novelty magnets and magnet sets.
Self-feeding devices such as baby bottle holders.
Absorbent beads.
Sky lanterns.
Novelty cigarettes.
Novelty lighters.
Beaded, amber teether pacifiers.
Mushroom-shaped teether pacifiers.
Neck floats for children.
Water walking balls.
Eclipse glasses and filters for daylight viewing.
Kites with metal parts.
Kites or kite lines for kite wars.
Balloon blowing kits containing dangerous toxins.
Toy crossbows, guns that can fire toothpicks, pins, etc.
Flammable candlesticks.
Fidget spinners with darts.
Sleep breathing patches.
Therapeutic and sensory swings.
Slime toys containing borax.
Angle grinder chain saw upgrade kits for converting angle grinders to chainsaws.
Flail cutting attachments for portable lawn mowers.
Whipped cream dispensers.
Event tickets, such as concert tickets, sporting event tickets
Immovable assets.
“Unopened” mystery boxes or similar products where the consumer cannot clearly identify the product to be received.
Products for which sale is prohibited by law or regulation.
Products subject to product bans by government agencies.

For example: products subject to Australian Competition and Consumer Commission (ACCC) product bans (Australian market).

Products designated by government agencies as posing a health or safety hazard.
Products subject to import sanctions.

Some jurisdictions impose import sanctions that restrict the import of certain goods from certain countries or origins into the United States, the European Union, or other jurisdictions. For example, sanctions administered by the US Treasury Department’s Office of Foreign Assets Control (OFAC) (US market).

Unauthorized products/items.

Recalled Goods

IMPORTANT: If sellers sell and promote goods on Temu, they must comply with all applicable laws, regulations, industry standards, and safety standards, as well as all Temu policies related to these goods, even if the goods are not explicitly described in our policies.

Temu focuses on product safety and compliance requirements, and actively pays attention to the safety and compliance of the products released and sold on Temu. Product recalls and other product safety warnings (including market withdrawals, sales stopping, product safety notices, etc.) usually indicate that the product risks endangering public health or causing harm. Temu prohibits the publication and sale of any products involved in recalls or other product safety warnings issued by recall agencies such as manufacturers, distributors, retailers or other suppliers, other recalling companies, government agencies, etc.

Sellers have an obligation to pay attention to and ensure the safety and compliance of the products they release and sell. The following links provide recall notices from government agencies in some countries/regions. Please note that these links are not exhaustive and are provided for general reference only, and Temu does not guarantee the accuracy of any information provided in these links.

II. Product Safety and Compliance Requirements

Temu is committed to working with sellers to help them better fulfill their product safety and compliance obligations and prevent illegal, unsafe and non-compliant goods from entering the Temu market. The following are some examples of product compliance requirements. These examples are not exhaustive and may vary depending on the country/ region where the product is listed or sold. Sellers are responsible for conducting the necessary research to ensure they fully understand and comply with all applicable product safety and compliance obligations. Please consult a professional legal advisor if sellers have any questions about product-related laws and regulations.

Note: All information, content, and materials provided below are not legal advice and are provided for general information purposes only. The included links are provided solely as additional information that may be useful, and Temu does not guarantee the accuracy of any information provided in these links.

Cosmetics

IMPORTANT: If sellers list and sell products on Temu, they must comply with all applicable laws, regulations, industry standards, safety standards, and all Temu policies related to those products, even if the product is not specifically described in our policies.

Note: The following information is not an exhaustive list of compliance requirements. Sellers are advised to consult professional legal counsel to ensure compliance with all applicable compliance requirements.

U.S. Market

Applicable laws and regulations

In the United States, cosmetics are regulated by the Food and Drug Administration (FDA). If the products released and sold in the United States are cosmetics, sellers should consult the Food, Drug, and Cosmetic Act (FD&C Act), Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the Fair Packaging and Labeling Program, the Microbead-Free Waters Act, and other applicable laws and regulations on cosmetics to ensure that the products released and sold comply with applicable laws and regulations and FDA requirements. For more information, see Cosmetics and cosmetics laws and regulations.

Sellers must also comply with applicable regional sales restrictions, such as Washington State’s Disposable Wipes and Toxic-Free Cosmetics Act (TFCA) and California’s Antiperspirant and Deodorant Regulations.

Definitions and Classification

Under the FD&C Act, cosmetics are articles intended to be applied to the human body or any part thereof by rubbing, pouring, sprinkling, spraying, introducing, or otherwise applying to the human body or any part thereof for the purpose of cleansing, beautifying, increasing attractiveness, or altering the appearance, and articles intended to be used as components of any such articles, but the term does not include soap. See the FD&C Act's definition of cosmetics. The MoCRA Act amended the FD&C Act to define a cosmetic as a preparation consisting of cosmetic ingredients of known quality and quantity for use in a finished product. Please refer to the definition of cosmetics under MoCRA.

Common cosmetics include skin creams, perfumes, lipsticks, nail polishes, make-up, shampoos, perms, hair dyes and deodorants. Some products meet the definition of both a cosmetic and a drug (see the FD&C Act's definition of a drug). This may occur when a good has multiple intended uses. For example, an anti-dandruff shampoo is a cosmetic because its intended use is to cleanse the hair, but it is also a drug because its intended use is to treat dandruff. Such products must meet the requirements of both cosmetics and medicines. For more information, see Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)

Compliance Check Examples

Facility Registration

Manufacturers and processors must register their facilities with the FDA and renew their registration every two years. For more information, see Registration & Listing of Cosmetic Product Facilities and Products.

Product Listings

Responsible persons (manufacturers, packers, or distributors of cosmetics whose names appear on the labels of such cosmetics) must list their cosmetics, including the cosmetic ingredients, with FDA and provide any updates annually. For more information, see Registration & Listing of Cosmetic Product Facilities and Products.

Cosmetic ingredients

Cosmetics should not contain prohibited ingredients or ingredients that do not meet restriction requirements. For more information, see Cosmetic Products & Ingredients, Prohibited & Restricted Ingredients in Cosmetics, Color Additives and Cosmetics: Fact Sheet, and U.S. Department of Justice Drug Enforcement Administration (DEA) Controlled Substances.

Cosmetic Safety

Cosmetics must be safe when consumers follow the directions on the label or use them in the customary or intended manner. The responsible person must ensure and keep records to demonstrate that their cosmetic products have adequate safety safeguards. Manufacturers can use existing relevant safety data to demonstrate the safety of cosmetic products. All data used to demonstrate safety should be derived from scientifically reliable methods. For more information, see Product Testing of Cosmetics

The MoCRA law requires industry to comply with the following regulations established by the FDA:

Good Manufacturing Practice (GMP) Requirements for Cosmetics Manufacturing Facilities
Fragrance Allergen Labeling Requirements
Standardized Test Methods for Detection and Identification of Asbestos in Talc-Containing Cosmetics

Exemptions

The MoCRA Act exempts certain small businesses from GMP, facility registration, and product listing requirements. For more information, see Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

Labels and information

Correct labeling is an important aspect of placing cosmetic products on the market. All cosmetics must be labeled in English. For more information, see Cosmetics Labeling.

Monitoring and reporting

The responsible person must report serious adverse events associated with the use of cosmetics in the United States to the FDA within 15 working days. For more information, see Cosmetics Compliance & Enforcement.

Product Statement

Do not make false or misleading statements
Do not claim or imply that the product can diagnose, cure, mitigate, treat, or prevent disease unless it is approved by the FDA and properly labeled as a cosmetic or drug
The statement “FDA approved” should not be used inappropriately. For more information, see Is It Really ‘FDA Approved’?
The FDA logo may not be used. For more information, see FDA Name and Logo Policy

EU and UK Markets

Applicable laws and regulations

Regulation (EC) No 1223/2009 (EU Cosmetics Regulation) applies to the supply and sale of cosmetics in the EU. The regulation lists many important requirements related to cosmetics, including notifying relevant departments before placing cosmetics on the EU market, ensuring the safety of cosmetics, prohibiting and restricting the use of certain substances, establishing a responsible person for cosmetics in the EU, and labeling requirements. For more information, see EU Cosmetics.

Sellers are responsible for complying with the EU Cosmetics Regulation and other applicable laws and regulations, and must also comply with the laws and regulations of applicable EU member states.

If sellers supply goods to the UK, they must comply with the requirements of the UK Cosmetics Regulations. Under the terms of Windsor Framework, sales into Northern Ireland will be subject to the relevant EU rules relating to the placing of finished products on the market, including the EU Cosmetics Regulation. For more information, see the Guidance on the regulations as they apply to cosmetic products being supplied in or into Great Britain and the Guidance on the regulations as they apply to cosmetic products being supplied in or into Northern Ireland.

Definition and classification

According to the EU Cosmetics Regulation, cosmetics are any substance or mixture intended to come into contact with the external parts of the human body (epidermis, hair, nails, lips, and external genitalia) or teeth and oral mucosa, whose sole or main purpose is to clean, perfume, change appearance, protect, maintain good condition or correct body odor.

Common cosmetics include skin creams, perfumes, lipsticks, nail polishes, make-up, shampoos, perms, hair dyes and deodorants. Sometimes, it may not be clear whether a product is a cosmetic under the EU Cosmetics Regulation or whether it is a product under other industry regulations. The classification of these borderline products must be decided on a case-by-case basis. European Commission has published guidance to facilitate the application of EU law in these situations. For more information, see Borderline products.

Compliance Check Examples

Person in charge

Cosmetics may only be placed on the market if a legal or natural person is designated as the responsible person within the EU. The Responsible Person may be the manufacturer, importer, or authorized representative (depending on the circumstances). For each cosmetic product placed on the market, the responsible person shall ensure compliance with the relevant obligations under the EU Cosmetics Regulation.

Product Notices

The responsible person and, in some cases, the distributor must submit information to the European Commission via the Cosmetic Product Notification Portal (CPNP)
CPNP also contains a separate module for cosmetic products containing nanomaterials. In addition to the aforementioned notification under Article 13 of the EU Cosmetics Regulation, cosmetics containing nanomaterials must also make this notification.

Cosmetic ingredients

Unless otherwise permitted, cosmetics may not contain carcinogenic, mutagenic or reproductive toxic substances (CMR substances). Even where permitted, labeling may be required.
Certain substances are prohibited and may not be used in cosmetics under any circumstances; certain substances may only be used in cosmetics in compliance with prescribed restrictions; colorants, preservatives, and UV filters, including nanomaterials, in cosmetics, must be explicitly authorized. For more information, see Annexes II to VI of the EU Cosmetics Regulation and the Cosmetic Ingredient Database.

Cosmetic Safety

Cosmetics should be safe for human health when used under normal or reasonably foreseeable conditions of use.
Cosmetics production should comply with good manufacturing practices
Safety Assessment and Product Information Documents

Cosmetics should undergo scientific and technical assessment before being marketed.
Product Information Files

When cosmetics are put on the market, the responsible person shall keep product information files. Product information files should be kept for ten years from the date the last batch of cosmetics was put on the market
The product information file should contain information and data from Article 11 of the EU Cosmetics Regulation and should be updated as necessary
The responsible person shall send the product information document in electronic or other format to the address stated on the label so that it is readily available to the competent authorities of the Member State in which it is kept
The information contained in the product information document should be provided in a language that can be easily understood by the competent authorities of the Member States

Certain cosmetic products receive special attention from regulators due to their scientific complexity or potential higher risks to consumers' health
Ban on animal testing

Labels and information

The containers and packaging of cosmetic products must contain the labeling and information in accordance with Article 19 of the EU Cosmetics Regulation in an indelible, legible, and visible font, with the key information in the language determined by the law of Member State where the cosmetic product is placed on the end-user

Monitoring and reporting

If the responsible person considers or has reason to believe that a cosmetic product he has placed on the market does not comply with the EU Cosmetics Regulation, he shall immediately take the necessary corrective measures to bring it into compliance, withdraw or recall the cosmetic product (as the case may be)
If a cosmetic product poses a risk to human health, the responsible person shall immediately notify the competent national authorities of the Member States to which the cosmetic product is supplied and of the Member States to which the product information document is readily accessible, providing detailed information, in particular on the non-compliance and the corrective measures taken
The responsible person shall, upon these authorities' request, cooperate with the authorities in any action they take to eliminate the risks posed by the cosmetic products they have placed on the market
The responsible person is obliged to notify serious adverse events (SUEs) to the Member State authorities. For more information, see Market Surveillance.

Product Statement

In the labeling, sales, and advertising of cosmetics, no words, names, trademarks, images, graphics or other signs may be used to imply that the cosmetics have properties or functions that they do not possess, and no false or misleading statements may be made. For more information, see:

Article 20 of the EU Cosmetics Regulation
Regulation (EU) No 655/2013 (EU Regulation on General Standards for Cosmetic Declarations)
Technical document on cosmetic claims

Food and Dietary Supplements

U.S. Market

Applicable Laws and Regulations

In the United States, food is regulated by the Food and Drug Administration (FDA). If the products released and sold by sellers in the United States are food, they should consult the Food, Drug, and Cosmetic Act (FD&C Act), the Food Safety Modernization Act (FSMA Act), the Fair Packaging and Labeling Act, and other applicable laws and regulations on food to ensure that the products released and sold comply with applicable laws and regulations and FDA requirements. Sellers must also comply with applicable regional selling restrictions. For more information, see Food.

Definitions and Classifications

Under the FD&C Act, food means any article intended for food or drink by humans or other animals, any chewing gum, or any article intended as a component of any such article.

Dietary supplements fall under the category of food, but they are a special type of food. Under the FD&C Act, dietary supplements include products (other than tobacco) that are intended to supplement the diet and contain or consist of one or more of the following dietary ingredients: vitamins, minerals, herbs or other botanicals, amino acids, or dietary substances, and concentrates, metabolites, components, extracts, or combinations of any of the foregoing. Dietary supplements come in a variety of forms, such as powders, pills, capsules, liquid drops, and oral sprays.

For more information, see Definitions of Foods and Dietary Supplements under the FD&C Act and Dietary Supplements.

Compliance Check Examples

Facility Registration

The owner, operator, or agent in charge of a U.S. or foreign facility that manufactures, processes, packs, or holds food for consumption in the United States must register its food facility with FDA and renew such registration every other year. For more information, see Registration of Food Facilities and Other Submissions.

Imported food

Prior Notice

Importers must comply with U.S. import procedures and prior notification requirements. For more information, see Importing Food Products into the United States.

Foreign Supplier Verification Program (FSVP) for Importers of Human and Animal Food

The importer for FSVP is the U.S. owner or consignee of the food being offered for import, or if there is no U.S. owner or consignee at the time of entry into the U.S., the U.S. agent/representative of the foreign owner or consignee.
FSVP requires importers to perform risk-based foreign supplier verification activities. Importers subject to the rule must implement an FSVP program to verify that their foreign suppliers produce foods in a manner that provides the same level of public health protection as preventive controls or produce safety regulations and to ensure that suppliers’ foods are not adulterated or mislabeled for allergens
For more information, see

Ingredients and packaging

Ingredients added directly to food and substances that come into contact with food are generally subject to the same safety standards, namely that they must be reasonably safe to be harmless under the conditions of intended use
FDA maintains a list of nearly 4,000 substances added to food of its public database. The list includes the following types of ingredients regulated by the FDA: food additives and color additives, as well as flavoring substances evaluated by the Flavor and Extract Manufacturers Association (FEMA) and the Joint Expert Committee on Food Additives (JECFA); Generally Recognized as Safe (GRAS) substances; substances approved for specific uses in food before September 6, 1958 (prior approved substances); previously used substances: substances listed in FDA regulations that are prohibited from use in food, color additives that have been delisted in FDA regulations, and some substances that are no longer FEMA GRAS. For more information, see Food Ingredients & Packaging and Substances Added Food (formerly EAFUS)

Current Good Manufacturing Practice (CGMP) and Hazard Analysis Critical Control Point (HACCP)

FDA established CGMP regulations in Title 21 of the Code of Federal Regulations (CFR) Part 117 as a part of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls rule for human food. In general, food facilities that are required to register with FDA under the FD&C Act must comply with the risk-based preventive controls rule in part 117 (unless an exemption applies). In addition to the CGMPs in part 117, FDA has published CGMPs for certain types of food. For more information, see Current Good Manufacturing Practices (CGMP) for Foods and Dietary Supplements
HACCP is a management system that addresses food safety by analyzing and controlling biological, chemical and physical hazards. This includes raw material production, procurement and processing, manufacturing, distribution and consumption of finished products. Prerequisite programs such as CGMP are an important foundation for developing and implementing a successful HACCP plan. For more information, see Hazard Analysis Critical Control Points (HACCP)

Labels and information

Food labels are required for most prepared foods, such as breads, cereals, canned and frozen foods, snacks, desserts, beverages, etc. Nutritional labeling for fresh produce (fruits and vegetables) and fish is voluntary. For more information, see 21 CFR Part 101 Food Labeling and Guidance for Industry: Food Labeling Guidance

Monitoring and reporting

Registered food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are required to report when there is a reasonable probability that use of or exposure to a food will cause serious adverse health consequences or death to humans or animals. If a manufacturer receives a report of a serious adverse event associated with a dietary supplement, the manufacturer is required by law to send the report to the FDA. For more information, see Compliance and Enforcement (Food)

Product Statement

Do not make false or misleading statements
The statement “FDA approved” should not be used inappropriately. For more information, see Is It Really “FDA Approved”?
The FDA logo may not be used. For more information, see FDA Name and Logo Policy
Do not claim or imply that your product can diagnose, cure, mitigate, treat, or prevent disease unless approved by the FDA.
There are three types of claims that can be used on food and dietary supplement labels: health claims, nutrient content claims, and structure/function claims. For information on the uses and limitations of these three types of food claims, see:

EU and UK Markets

Applicable laws and regulations

The EU has many regulatory restrictions on food and food products. EU food legislation sets out, in particular, strict standards for controlling the hygiene, animal health and safety, and plant quarantine of food and food products, and for preventing contamination by external agents. See Food for more information.

Regulation (EC) No 178/2002 (EU General Food Regulation) is the basic EU legislation for food and feed. It sets out an overall and coherent framework for food and feed legislation at EU and national level. To this end, it sets out general principles, requirements and procedures for decision-making on food and feed safety, covering all stages of food and feed production and distribution. It also establishes an independent body responsible for providing scientific advice and support, the European Food Safety Authority (EFSA). In addition, it develops key procedures and tools for emergency and crisis management and the Rapid Alert System for Food and Feed (RASFF). For more information, see General Food Law.

Sellers are responsible for complying with the EU General Food Regulation and all applicable laws and regulations, and must also comply with the laws and regulations of applicable EU member states.

If sellers supply goods to the UK, they must comply with the UK General Food Regulations and all applicable laws and regulations. Under the Northern Ireland Protocol, food and feed sold in Northern Ireland must comply with EU laws and regulations. For more information, see the UK Food Standards Agency General Food Law.

Definition and Classification

According to the EU General Food Regulation, food means any substance or product, whether processed, partially processed or unprocessed, intended or reasonably expected to be consumed by humans. Food includes beverages, chewing gum and any substance (including water) intentionally added to food during the manufacture, preparation or handling of food. Feed means any substance or product, including additives, intended for oral administration to animals, whether processed, partially processed or unprocessed.

Food supplements are foods that supplement the normal diet. Food supplements are foods and therefore, subject to the requirements of the EU General Food Regulation. In addition, food supplements are subject to the harmonized rules in Directive 2002/46/EC (EU Food Supplements Directive), which are designed to protect consumers from potential health risks and ensure that they do not receive misleading information.

According to the EU Food Supplements Directive, food supplements are foods used to supplement the normal diet, are concentrated sources of nutrients or other substances with nutritional or physiological effects, sold alone or in combination in dosage forms, i.e. capsules, lozenges, tablets, pills and other similar forms, powder bags, liquid ampoules, dropper bottles and other similar forms of liquids and powders, intended to be taken in small quantitative units; nutrients refer to vitamins and minerals.

Compliance Check Examples

Food Business Operator (FBO) Registration

According to Regulation (EC) No 852/2004 (EU Food Hygiene Regulation), the primary responsibility for food safety lies with food business operators (FBOs). Each FBO shall notify the appropriate competent authority of each establishment under its control that conducts all stages of food production, processing and distribution in a manner required by that authority for the purpose of registering each such establishment.

Pre-marketing notifications

Infant and toddler foods, foods for special medical purposes and complete meal replacements for weight management

Regulation (EU) No 609/2013 (EU Regulation on Infant Food, Food for Special Medical Purposes and Total Dietary Alternatives for Weight Control) stipulates the notification requirements for the placing of infant food, food for special medical purposes and total dietary alternatives for weight control on the market. In order to facilitate effective official control of such foods, FBOs should notify the competent authorities of the member states where the food is sold accordingly. See Food for Specific Groups and List of Competent Authorities

Food Supplements

EU member states may require notification of food supplements placed on the market in their territory for monitoring purposes. Once a food supplement is on the market, the competent authorities of the EU member states can monitor its use in the region. See the list of food supplements and EU member state competent authorities

Special restrictions on certain foods

Novel foods: Novel foods must be authorized before they can be placed on the EU market, see Novel food
Food additives, food enzymes and food flavorings

Food additives: All food additives in the EU must be authorized. The list of additives approved for use in food and their conditions of use are contained in Annex II to Regulation (EC) No 1333/2008 (EU Food Additives Regulation). You can also refer to the EU Food Additive Database.
Food enzymes: All food enzymes must undergo EFSA safety assessment and be approved by the European Commission to be included in the EU food enzyme list. There is currently no list of authorized food enzymes. Until this evaluation is completed, the marketing and use of food enzymes and foods produced with them are subject to the legislation of the EU member states. See Enzymes
Food flavorings: The food industry may only use flavoring substances on the EU food flavoring list, which can be found in the Food Flavorings Database.

Fortified foods

The addition of nutrients or other substances to fortify foods does not fall within the definition of food supplements; they are regulated by Regulation (EC) No 1925/2006. See Addition of Vitamins and Minerals

Annex I lists the vitamins and minerals that can be added to food.
Annex II lists sources of vitamins and minerals that can be added to food.
Annex III lists substances other than vitamins or minerals that are prohibited, restricted, or under review in food.

Food Contact Materials (FCM)

All food contact materials (FCM) must comply with Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with foodstuffs. In addition, all FCMs must be produced in accordance with good manufacturing practices of Regulation (EC) No 2023/2006 and specific EU legislation for certain materials (including plastics and ceramics), and national legislation for other materials. Some regulations on FCMs (such as the Plastic Materials and Articles Regulation) specify lists of substances. Once listed, the substances can be used with restrictions and regulations in mind. See Food Contact Materials

Food safety and sanitation

Unsafe food must not be put on the market. FBOs should ensure that all stages of food production, processing and distribution under their control comply with relevant hygiene requirements. FBOs should comply with the general and specific hygiene requirements of the EU Food Hygiene Regulation. The FBO shall establish, implement and maintain one or more permanent procedures based on Hazard Analysis and Critical Control Point (HACCP) principles.
For more information on food hygiene rules and other matters concerning foods of animal origin, please see:

Regulation (EC) No 853/2004 (EU Regulation on the Hygiene of Food of Animal Origin)
Regulation (EU) 2017/625 (EU Official Control Regulation)
EU Food Hygiene

Labels and information

Regulation (EU) No 1169/2011 (EU Food Consumer Information Regulation, EU FIC Regulation) sets out the mandatory labeling requirements applicable to food. Any food supplied to the final consumer or mass catering services must be accompanied by food information in accordance with the EU FIC Regulation. Food information must not be misleading and should be accurate, clear and easy for consumers to understand. For pre-packaged foods, mandatory food information should be marked directly on the packaging or on a label attached to the packaging. For pre-packaged foods sold by distance communication means, mandatory food information should be provided before the purchase is completed and should appear on materials supporting distance selling or be provided by other appropriate means expressly specified by the FBO. Certain food types may be subject to specific regulations and should meet additional labeling requirements. For more information, see:

Monitoring and reporting

If an FBO considers or has reason to believe that a food it imports, produces, processes, manufactures or distributes does not comply with food safety requirements, it should immediately initiate procedures to withdraw the relevant food and notify the competent authority. If the food may have reached consumers, consumers should be informed effectively and accurately of the reason for the withdrawal and, if necessary, the food should be recalled.
If an FBO considers or has reason to believe that food it places on the market may be harmful to human health, it shall immediately notify the competent authority. FBOs should inform the competent authorities of actions they have taken to prevent risks to final consumers and should not prevent or hinder anyone from cooperating with the competent authorities to prevent, reduce or eliminate risks posed by food, in accordance with national law and legal practice.
FBOs should work with competent authorities to take actions to avoid or reduce risks from food they supply or have supplied.

Product Statement

Regulation (EC) No 1924/2006 ensures that any claims on food labels, displays or advertisements in the EU are clear, accurate and based on scientific evidence, and prohibits the sale of foods with claims that are likely to mislead consumers.
The EU Register of Health Claims lists all permitted nutrition claims and their conditions of use, authorized health claims, their conditions of use and applicable limitations (if any), and unauthorized health claims and the reasons why they were not authorized. Serve as a reference source, thereby ensuring full transparency for consumers and FBOs.

Drug-related Products

IMPORTANT: If sellers list and sell products on Temu, they must comply with all applicable laws, regulations, industry standards and safety standards, and all Temu policies related to these products, even if the product is not explicitly described in our policies.

U.S. Market

Applicable laws and regulations

In the United States, drugs are regulated by the Food and Drug Administration (FDA). If the products released and sold in the United States are drugs, sellers should consult the Food and Drug Act of 1996, the Food, Drug, and Cosmetic Act (FD&C Act), the Food and Drug Administration Amendments Act (FDAAA), and other applicable laws and regulations regarding drugs to ensure that the products released and sold comply with applicable laws and regulations and FDA requirements. Sellers must also comply with applicable regional selling restrictions. For more information, see Drugs and Importing Human Drugs.

Definition and Classification

Under the FD&C Act, drugs include articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals and articles (other than food) intended to affect the structure or any function of the body of man or other animals. The definition also includes pharmaceutical ingredients, such as active pharmaceutical ingredients. See the FD&C Act's definition of a drug.

Some products may meet the definitions of both cosmetics and drugs. Such products must meet the requirements of both cosmetics and drugs. For more information, see Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?).

Some medicines require a prescription for sales, such as most antibiotics. Other drugs can be sold without a prescription because they are FDA-approved for sale as over-the-counter drugs. Please note that Temu prohibits the publication or sale of prescription drugs.

Compliance Check Examples

Institutional Registration

With certain exemptions, any facility that manufactures, repacks, relabels, or salvages drugs for distribution in the U.S. must register with FDA and renew registration annually. For more information, see the Electronic Drug Registration and Listing Instructions, Human Drug Establishment Registration and Drug Listing Compliance, the Drug Establishment Current Registration Site (DECRS) Database, and the Electronic Drug Registration and Listing System (eDRLS).

Product Listings

All registered facilities are required to list all drug products they manufacture and distribute in the United States under their own labeler code and submit updated drug listing information to FDA twice a year (June and December). For more information, see the Electronic Drug Registration and Listing System (eDRLS), Human Drug Establishment Registration and Drug Listing Compliance, and the Electronic Drug Registration and Listing Instructions.

Drug Approval and National Drug Code (NDC)

Drug application types include Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Over-the-Counter (OTC) and Biologics License Application (BLA). OTC drugs are medicines available to consumers without a prescription and include more than 80 therapeutic categories, ranging from acne medications to weight management drugs. Please visit the Types of Applications page for more information.
Drugs are identified and reported using a unique three-part number called the National Drug Code (NDC), which is the FDA's universal commodity identifier for drugs. A NDC must be submitted when a drug is listed with the FDA. For more information, see How Drugs are Developed and Approved and the National Drug Code Directory.

Drug Safety and Quality

Compliance with laws related to drug safety and quality is the industry's responsibility. Key requirements for drug manufacturing quality include FD&C Act and the current good manufacturing practices (CGMP). Pharmaceutical CGMPs contain minimum requirements for methods, facilities, and controls used in the manufacture, processing, and packaging of drug products. These requirements ensure that medicines are safe for use and with the ingredients and strengths they claim to have. For more information, see Current Good Manufacturing Practices (CGMP) Regulations and Pharmaceuticals Inspection and Compliance.

Labels and information

The labeling requirements for drugs depend on the type of drug (e.g., prescription drug versus OTC drug). For more information on labeling requirements, see the Guidelines | Drugs and OTC Drug Facts Label.

Post-Market Requirements (PMRs) and Commitments (PMCs)

PMRs and PMCs refer to studies and clinical trials conducted by sponsors after approval to gather more information about the safety, effectiveness, or best use of a product. Some studies and clinical trials may be required; others may be studies or clinical trials that a sponsor has committed to conduct. For more information, see Postmarketing Requirements and Commitments: Introduction and Guidance, Compliance and Regulatory Information

Product Statement

Do not make false or misleading statements. For more information, see Medication Health Fraud.
Do not claim or imply that the product can diagnose, cure, mitigate, treat, or prevent disease unless approved by the FDA and properly labeled as a cosmetic or drug.
The statement “FDA approved” should not be used inappropriately. For more information, see Is It Really “FDA Approved”?
The FDA logo may not be used. For more information, see FDA Name and Logo Policy.

A drug agency registration number or a drug NDC number does not indicate approval of the company or its products. Any representation that gives the impression of official approval because of registration or the possession of a registration number or NDC number is misleading and in violation of federal law.

EU and UK markets

In the EU and UK, businesses selling medicines to the public online must comply with the requirements of Directive 2011/62/EU (the EU Falsified Medicines Directive) and the UK Human Medicines Regulations 2012 by registering on the national/regional lists and displaying the distance selling logo on the website where the medicines are sold. For more information, see EU logo for online sale of medicines and UK Register for the Distance Selling logo.

Please note that as of now, Temu prohibits sellers from listing and selling pharmaceutical products in the EU and UK markets.

Medical Devices

U.S. Market

Applicable Laws and Regulations

In the United States, medical devices are regulated by the Food and Drug Administration (FDA). If the products released and sold in the United States are medical devices (including medical device accessories), sellers should consult the Food, Drug, and Cosmetic Act (FD&C Act) and other applicable laws and regulations regarding medical devices to ensure that the products released or sold comply with applicable laws and regulations and FDA requirements. For more information, see Medical Devices.

Sellers must also comply with applicable regional selling restrictions. Examples of regional selling restrictions include: reading glasses, etc.

Definition and Classification

Under the FD&C Act, medical devices include instruments, apparatus, implements, machines, devices, implants, in vitro reagents, or other similar or related articles, including any components, parts, or accessories, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals or in affecting the structure or any function of the body of man or other animals. See the FD&C Act's definition of medical device.

FDA has established classifications for approximately 1,700 different general purpose devices, each of which is assigned to one of three regulatory categories: Class I, II, or III, based on the level of control required to ensure the device’s safety and effectiveness. Class I includes the lowest-risk medical devices, and Class III includes the highest-risk medical devices. From Class I to Class III, regulatory control gradually increases. For more information, see How to Determine if Your Product is a Medical Device and Classify Your Medical Device.

Some medical devices are over-the-counter ones sold to consumers, while others are for professional use and require prescription. FDA distinguishes between prescription and over-the-counter medical devices by evaluating the intended use of the device and the safety of operating the device. Please note that Temu prohibits the listing or sale of professional use and prescription medical devices.

Compliance Check Examples

Institutional Registration

The owner or operator of a facility involved in the manufacture and distribution of medical devices intended for use in the United States must register annually with the FDA. For more information, see Who Must Register, List and Pay Fee and the Establishment Registration and Device Listing Database

Product Listings

Most businesses that are required to register must also list the medical devices the business manufactures and the activities that are performed on those devices. For more information, see Who Must Register, List and Pay Fee and the Establishment Registration and Device Listing Database

Premarket Notification 510(k) and Premarket Approval (PMA)

Most Class I medical devices and some Class II medical devices are exempt from the premarket notification 510(k) requirement and do not require FDA review before marketing. For exempt Class I and Class II medical devices, see Medical Device Exemptions 510(k) and GMP Requirements.
Class I and Class II medical devices not exempted from the requirement must obtain a premarket notification 510(k) before they can be legally marketed. For more information, see 510(k) Clearances and 510(k) Premarket Notification Database
Most Class III medical devices require pre-market approval (PMA) before they can be legally marketed.

Unique Device Identifier (UDI)

The UDI is a unique numeric or alphanumeric code that is usually composed of:

The Device Identifier (DI) is a mandatory fixed part of the UDI and is used to identify the labeler and the specific version or model of the device.
The Production Identifier (PI) is a conditional, variable portion of the UDI that, when included on a device label, may identify one or more of the following:

The batch or lot number of the device manufactured.
Serial number of the specific device
Expiration date for specific equipment
The date the specific device was manufactured.

Labelers must provide the UDI on labels and packaging in two forms:

Easy-to-read plain text
Machine-readable forms using Automatic Identification and Data Capture (AIDC) technology

Labelers must also display the date on device labels and packaging in a standard format (YYYY-MM-DD) that complies with international standards and practices.
Labelers must submit device information to the Globally Unique Device Identifier Database (GUDID) managed by the FDA.
For more information, see UDI Basics.

Quality System

Manufacturers must establish and follow a quality system to ensure that their goods consistently comply with applicable requirements and specifications. FDA has established quality system regulations (QSRs) to address the problems of medical device design and validation and good manufacturing practices. For more information, see Quality System (QS) Regulation/Medical Device Current Good Manufacturing Practices (CGMP)

Labels and information

Labeling includes the label on the medical device and the descriptive and informational literature that accompanies the medical device. All medical devices must be labeled in English. For more information, see Device Labeling and General Device Labeling Requirements.

Monitoring and reporting

Mandatory reporters (i.e., manufacturers, using facilities, and importers) are required to report certain medical device-related adverse events and product problems to the FDA. For more information, see Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities

Product Statement

Do not make false or misleading statements
The claim “FDA approved” must be used appropriately. For more information, see Is It Really “FDA Approved”?
The FDA logo may not be used. For more information, see FDA Name and Logo Policy.
The FDA does not "certify" medical devices, issue registration certificates to medical device facilities, or certify information about facilities that have registered and listed their medical devices. When a facility registers and lists its medical devices, results in the FDA registration and listing database do not indicate that the facility or its medical devices have been approved, cleared, or authorized. Please see Important Reminders about Registration and Listing.

EU and UK Markets

Applicable laws and regulations

Regulation (EU) 2017/745 (EU MDR) applies to the supply and sale of medical devices (including medical device accessories) within the EU. In vitro diagnostic medical devices and implantable devices are not subject to the EU MDR, but fall within the scope of Regulation (EU) 2017/746 (EU IVDR). The EU MDR and IVDR regulations contain EU requirements for the marketing of medical devices, in vitro diagnostic medical devices and implantable devices, including classification, compliance requirements and registration obligations.

The EU MDR and IVDR regulations replace: Directive 93/42/EEC (EU Medical Device Directive, EU MDD Directive), Directive 98/79/EC (EU In Vitro Diagnostic Medical Devices Directive, EU IVDMD Directive) and Directive 90/385/EEC (EU Active Implantable Medical Devices Directive, EU AIMDD Directive). However, the EU MDR and EU IVDR regulations provide for a transition period. For more information on the transition period and the applicability of new regulations, please refer to the new regulations and guidance on the new regulations.

Sellers are responsible for complying with the EU MDR and IVDR regulations and other applicable laws and regulations, and must also comply with the laws and regulations of applicable EU member states.

If sellers supply goods to the UK, they must comply with the requirements of the UK Medical Devices Regulations 2002 (UK MDR regulations). In vitro diagnostic medical devices and implantable devices are also subject to the UK MDR regulations. Under the Northern Ireland Protocol, the rules for placing medical devices on the market in Northern Ireland differ from those in the United Kingdom (England, Wales and Scotland). For more information on Northern Ireland's medical device regulatory system, see Regulating medical devices in the UK.

Definition and Classification

According to the EU MDR regulation, medical devices are any instruments, equipment, appliances, devices, software, implants, reagents, materials or other articles that the manufacturer intends to be used alone or in combination for the human body and for one or more of the following specific medical purposes:

Diagnosis, prevention, monitoring, prediction, prognosis, treatment or mitigation of disease
Diagnosis, monitoring, treatment, relief, or compensation for injury or disability.
Study, replace or modify anatomical structures or physiological or pathological processes or conditions.
Providing information through in vitro examination of human samples (including organ, blood and tissue donations) whose primary intended effect is not achieved in or on humans by pharmacological, immunological or metabolic means, but whose function may be assisted by such means.

The following products should also be considered as medical devices:

Devices used to control or support conception;
Products designed specifically for cleaning, disinfecting or sterilizing medical devices.

According to the EU MDR regulations, medical devices are classified according to risk into Class I (low risk), Class IIa and Class IIb (medium risk), and Class III (high risk). Class I medical devices are further divided into ordinary Class I, Class Is, Class Im and Class Ir. For the classification rules of medical devices, please refer to Annex VIII of the EU MDR Regulation and the EU Guidance on classification of medical devices.

Compliance Check Examples

Safety and performance

Medical devices (including medical device accessories) must comply with the safety and performance requirements set out in Annex I of the EU MDR Regulation.

Quality Management System

Manufacturers should ensure that procedures are in place to enable serial production to comply with the EU MDR requirements. For more information, see Annex IX of the EU MDR Regulation.

Conformity Assessment

Conformity Assessment Procedures

Medical devices must undergo appropriate conformity assessment procedures to ensure compliance with the requirements of the EU MDR regulations.
Manufacturers should conduct clinical evaluations in accordance with the requirements of Article 61 and Annex XIV of the EU MDR.
Class I medical devices do not require the involvement of a Notified Body unless they have a measuring function or are placed on the market under sterile conditions. Class III medical devices and representative medical devices of Class IIa and IIb must be reviewed by a Notified Body (NANDO)

Create technical documentation

Manufacturers must establish technical documentation that should be able to assess whether the medical device complies with the requirements of the EU MDR regulation. Technical documentation should include the elements specified in Annex II and III of the EU MDR

Drafting and signing of the EU Declaration of Conformity

If compliance with applicable requirements is demonstrated under the applicable conformity assessment procedure, except for custom-made devices or investigational devices, the manufacturer shall draw up and sign an EU Declaration of Conformity and affix the CE marking
The EU Declaration of Conformity should indicate that the covered medical device has met the requirements of the EU MDR Regulation
The EU Declaration of Conformity should contain at least the information specified in Annex IV of the EU MDR Regulation and should be continuously updated
The EU Declaration of Conformity should be translated into an official EU language or the language required by the country where the medical device is produced
If a medical device is regulated by more than one EU legislation requiring an EU Declaration of Conformity, one EU Declaration of Conformity should be drawn up for all of these EU legislations

File Saving

The manufacturer shall keep a copy of technical documentation, the EU Declaration of Conformity and, where applicable, any relevant certificates issued by the notified body available for inspection by the competent authorities for at least 10 years after the last medical device was placed on the market. For implantable medical devices, this period shall be at least 15 years after the last medical device was placed on the market.
Upon request from the competent authorities, the manufacturer shall provide them with all the information and documents necessary to demonstrate the conformity of the medical device in the official EU language determined by the Member State concerned. Manufacturers with a registered place of business outside the EU should ensure that the authorized representative is able to permanently keep the necessary documents and fulfill the corresponding obligations on their behalf.

CE marking

All medical devices, except custom-made or research devices, should be CE marked.
The CE marking shall be clearly visible and indelibly affixed to the medical device or its sterile packaging. If affixation is not possible or cannot be guaranteed due to the nature of the medical device, the CE marking shall be affixed to the packaging. The CE marking should also appear on any instructions for use and any sales packaging.
Where applicable, the CE marking shall be followed by the identification number of the notified body. The identification number should also be included in any promotional material stating that the medical device complies with CE marking requirements.

Registration of medical devices and economic operators

Manufacturers are required to comply with the obligations relating to the UDI system as set out in Article 27 of the EU MDR and the registration obligations as set out in Articles 29 and 31. For more information, see UDI Assignment and EUDAMED - European Database on Medical Devices.

Labels and information

Medical devices must be accompanied by the information specified in Article 23 of Annex I of the EU MDR Regulation, in the official Union language determined by the Member State where the medical device is provided to the user or patient. The detailed information on the label should be indelible, easy to read and clearly understood by the intended user or patient.

Monitoring and reporting

If a manufacturer believes or has reason to believe that a medical device it has placed on the market or put into use does not comply with the requirements of the EU MDR regulations, it should immediately take the necessary corrective measures to bring the medical device into compliance with the regulations, or withdraw or recall the medical device as appropriate. The manufacturer should inform the relevant distributors and, where applicable, the authorized representative and importer
If a medical device presents a serious risk, the manufacturer shall immediately notify the competent authorities of the Member States to which the medical device is supplied and, where applicable, notify the notified body, in particular, of the non-compliance and any corrective measures taken
Upon request by the competent authority, the manufacturer shall cooperate with the competent authority in taking any corrective measures to eliminate or mitigate the risks posed by the medical devices which has been placed on the market or put into service
Manufacturers should establish a system for recording and reporting incidents and field safety corrective actions as required by Articles 87 and 88 of the EU MDR

Product Statement

Do not make false or misleading statements
The CE mark shall not be affixed to goods that do not fall within the scope of labeling regulations. The CE mark does not indicate that the goods have obtained safety certification from the EU or other institutions, nor does it indicate the origin of the goods. See CE marking guidelines.

Electrical and Electronic Products

U.S. Market

Electrical Safety

The Consumer Product Safety Act (CPSA) for U.S. market came into effect on October 27, 1972. It aims to establish the Consumer Product Safety Commission (CPSC) and clarify its authority. Its purpose is to protect the public from unreasonable risks of injury associated with consumer products, help consumers evaluate the relative safety of consumer products, establish uniform safety standards for consumer products, and promote research and investigation into the causes and prevention of product-related deaths, illnesses, and injuries. The Consumer Product Safety Improvement Act (CPSIA) amended the CPSA and provided the CPSC with significant new regulatory and enforcement tools as part of an effort to amend and strengthen multiple CPSC regulations, including the CPSA.

Examples of electrical and electronic products regulated by the CPSA and CPSIA:

16 CFR Part 1120 Seasonal Lighting (Holiday Lights and Decorative Outfits)

According to UL588, minimum wire diameter, adequate strain relief and overcurrent protection must be met.

16 CFR Part 1120 Hand-Supported Hair Dryers Business Guidance

According to the requirements of UL859 and UL1727, it must be equipped with an integral water immersion protection device.

16 CFR Part 1120 Extension Cords

According to UL817, minimum wire diameter, adequate strain relief, correct polarization, correct continuity, socket covers and jacketed cables must be met.

16 CFR Part 1204 Omnidirectional Citizens Band Antennas
16 CFR Part 1205 Power Lawn Mowers (Walk Behind)
16 CFR Part 1211 Automatic Residential Garage Door Operators
16 CFR Part 1263 Button Cell and Coin Cell Batteries

For more information, see CPSC Business Education.

Radio Frequency Devices

In the United States, the Federal Communications Commission (FCC) regulates radio frequency (RF) devices contained in electrical products that are capable of radiating, conducting, or otherwise emitting RF energy. These products may cause interference to radio services in the radio frequency range of 9kHz to 3000GHz. The FCC's rules and regulations are found in Title 47 of the Code of Federal Regulations (CFR). For more information, see Rules & Regulations for Title 47.

Almost all electrical products are capable of radiating RF energy. Most products must be tested to demonstrate compliance with the FCC Rules and Regulations for each electrical function contained in the product. For more information, refer to Equipment Authorization – RF Device.

Compliance Inspection Project Examples

“Covered List” Equipment

Beginning February 6, 2023, any device identified on the FCC’s “covered list” will be prohibited from obtaining equipment authorization from the FCC. For more information, see Prohibition on Authorization of “Covered” Devices.

Device Authorization

Certification:

Tested by an FCC-approved certification testing laboratory
The person in charge (usually the manufacturer) obtains the FCC Registration Number (FRN) for the device that requires certification
The person in charge submits the certification application to the Telecommunications Certification Body (TCB) and obtains the certification certificate.

Supplier Declaration of Conformity (SDoC):

Testing is required, but not by an FCC-approved certification testing laboratory.
The responsible person maintains all necessary documentation to demonstrate that each device complies with applicable FCC rules.
The responsible person prepares a compliance information statement to accompany the product when it is put on the market.

Labels and information

Label the equipment and provide necessary information. The FCC ID is usually displayed on a label on a certified RF device, indicating that the device has been certified by the FCC. For more information, see Labeling Guidelines and FCC ID Search

Energy Labeling

The Energy Policy and Conservation Act requires that the following products be subject to the Energy and Water Use Labeling for Consumer Products under the Energy Policy and Conservation Act (Energy Labeling Rule):

Display EnergyGuide labels on product detail pages for certain appliances.
Display the Lighting Facts tab on product detail pages for certain lighting products.
Display the energy icon (a capital letter E in a circle) on product detail pages for certain lighting products
Displaying water usage information on product detail pages for certain plumbing products.

Please contact the product manufacturer or trademark holder to obtain the appropriate label, icon, or water usage information to comply with energy labeling rules.

For more information, see the U.S. Federal Trade Commission (FTC) Appliance Manufacturers FAQs about the EnergyGuide Labeling and Lighting Facts labels.

Button or Coin Cell Batteries and Consumer Products Containing such Batteries

Requirements of the Consumer Product Safety Act (CPSA) and the Consumer Product Safety Improvement Act (CPSIA):

Certain general purpose products that are subject to a similar rule, ban, standard, or regulation under the Consumer Product Safety Rule or any other CPSC-enforced regulation must demonstrate compliance with the applicable safety rule in the form of a written General Certificate of Conformity (GCC). GCC and test reports must be in English.
Children's products subject to the federal children's product safety rules must demonstrate compliance with the applicable safety rules in the form of a written Children's Product Certificate (CPC) based on test results from a CPSC-accepted testing laboratory. CPC and the test report must be in English.

Some mandatory rules for button or coin cells and consumer products containing them are found in:

For more information, see:

EU and UK Markets

EU LVD Directive

Directive 214/35/EU (EU Low Voltage Directive, EU LVD Directive) specifies requirements for electrical equipment intended to be used within specific voltage limits in order to provide a high level of health and safety protection for persons, domestic animals, and property.

Sellers are responsible for complying with the EU LVD Directive and other applicable laws and regulations, and must also comply with the laws and regulations of applicable EU member states.

If you supply goods to the UK, you must comply with the requirements of the UK Electrical Equipment (Safety) Regulations (EESR Regulations), which apply throughout the UK, but some of the provisions apply differently in Northern Ireland under the terms of the Windsor Framework. For more information, see Guidance on the regulations as they apply to equipment being supplied in or into Great Britain and Guidance on the regulations as they apply to equipment being supplied in or into Northern Ireland.

Definition and Classification

The EU LVD Directive applies to electrical equipment designed for rated voltages of 50 to 1000V AC and 75 to 1500V DC, except for equipment listed in Annex II of the EU LVD Directive.

Compliance Inspection Project Examples

Safety Goals

The EU LVD Directive states that electrical equipment must not endanger the safety of persons, animals, or property when properly installed, maintained, and used for the purpose for which it was manufactured.
The key safety objectives of electrical equipment are listed in Annex I of the EU LVD Directive

Quality System

Manufacturers should ensure that procedures are in place so that serial production complies with the requirements of the EU LVD Directive.

Conformity Assessment

Conformity Assessment Procedures

Electrical equipment must undergo an appropriate conformity assessment procedure to ensure compliance with the requirements of the EU LVD Directive.
The conformity assessment of electrical equipment adopts the internal production control procedure performed by the manufacturer without the involvement of a third party. The details of the procedure are set out in Annex III of the EU LVD Directive.

Create technical documentation

Manufacturers must establish technical documentation that should be able to assess whether electrical equipment complies with the requirements of the EU LVD Directive and should include a full analysis and assessment of the risks. The technical documentation should specify the applicable requirements and, as far as possible, cover the design, manufacture, and operation of the electrical equipment relevant to the assessment. The technical documentation shall contain at least the elements specified in Annex III of the EU LVD Directive, where applicable.

Drafting and signing the EU Declaration of Conformity

When electrical equipment complies with applicable safety requirements, the manufacturer shall draw up and sign the EU Declaration of Conformity and affix the CE mark.
The EU Declaration of Conformity should indicate that the safety objectives set out in Article 3 of the EU LVD Directive and listed in Annex I have been demonstrated to be met.
The EU Declaration of Conformity shall have the model structure specified in Annex IV of the EU LVD Directive, shall contain the elements specified in Module A as specified in Annex III and shall be continuously updated.
The EU Declaration of Conformity should be translated into one or more languages required by the Member State where the electrical equipment is placed on the market.
If electrical equipment is regulated by more than one EU legislation requiring an EU Declaration of Conformity, one EU Declaration of Conformity should be drawn up for all of these EU legislations.

File Saving

After placing electrical equipment on the market, the manufacturer must keep the technical documentation and the EU Declaration of Conformity for 10 years.
Upon reasonable request from a national competent authority, the manufacturer shall provide that authority with all necessary paper or electronic information and documents required to demonstrate compliance with the requirements in a language that can be easily understood by that authority.

CE marking

Electrical equipment must be CE marked before being placed on the market.
The CE mark shall be clearly visible and indelibly affixed to the electrical equipment or its nameplate. If the affixing of the CE marking is not possible or warranted due to the nature of the electrical equipment, it shall be affixed to the packaging and accompanying documents.

Labels and information

Electrical equipment should be marked with the manufacturer's name, registered trade name or registered trademark and a contact postal address. If this is not possible, it should be marked on the packaging or accompanying documents. The address should indicate a single address where the manufacturer can be contacted. Contact details should be provided in a language that is easily understandable to end users and market surveillance authorities.
Electrical equipment should be marked with the importer's name, registered trade name or registered trademark and contact postal address. If this is not possible, it should be marked on the packaging or accompanying documents. Contact details should be provided in a language easily understandable to end users and market surveillance authorities.
Electrical equipment should be marked with the type, batch, serial number or other identifiable element, or, when the size or nature of the electrical equipment does not allow, on the packaging or accompanying documents.
Electrical equipment should be accompanied by instructions and safety information in a language that is easily understood by consumers and other end-users, the specific language being determined by the Member State concerned. Such instructions and safety information and any labeling should be clear, understandable and easily understood.

Monitoring and reporting

If a manufacturer believes or has reason to believe that electrical equipment it has placed on the market does not comply with the EU LVD Directive, it shall immediately take the necessary corrective measures to bring the electrical equipment into compliance with the EU LVD Directive and, where appropriate, withdraw or recall the equipment.
If electrical equipment presents a risk, the manufacturer shall immediately notify the competent national authorities of the Member States in which it places the electrical equipment on the market, detailing the non-compliance and any corrective measures taken.
Manufacturers should cooperate with the competent authorities in taking all measures to eliminate the risks posed by the electrical equipment they put on the market in accordance with their requirements.

Product Statement

Do not make false or misleading statements
The CE mark shall not be affixed to goods that do not fall within the scope of labeling regulations. The CE mark does not indicate that the goods have obtained safety certification from the EU or other institutions, nor does it indicate the origin of the goods. See CE marking guidelines.

EU EMC Directive

Directive 2014/30/EU (European Union Electromagnetic Compatibility Directive, EU EMC Directive) aims to ensure that equipment that is susceptible to or affected by electromagnetic disturbances can be used in the electromagnetic environment for which it was designed without causing interference to other equipment or being affected by them.

Sellers are responsible for complying with the EU EMC Directive and other applicable laws and regulations, and must also comply with the laws and regulations of applicable EU member states.

If you supply goods to the UK, you must comply with the requirements of the UK Electromagnetic Compatibility Regulations, which apply throughout the UK, but some of the provisions apply differently in Northern Ireland under the terms of the Windsor Framework. For more information, see the Guidance on the regulations as they apply to products being supplied in or into Great Britain and Guidance on the regulations as they apply to products being supplied in or into Northern Ireland.

Definition and Classification

The EU EMC Directive covers equipment sold to end users as a single functional unit liable to generate electromagnetic interference or whose performance may be affected. It does not cover equipment intended for fixed installation and is not otherwise available on the market. The EU EMC Directive does not apply to equipment covered by Directive 1999/5/EC. Aviation products and radio equipment used by amateur radio operators are also not within the scope of the directive.

Compliance Inspection Project Examples

Basic Requirements

Manufacturers should ensure that the equipment they design and manufacture complies with the essential requirements set out in Annex I of the EU EMC Directive.

Quality System

The manufacturer should ensure that procedures are in place so that series production complies with the requirements of the EU EMC Directive.

Conformity Assessment

Conformity Assessment Procedures

Equipment must undergo an appropriate conformity assessment procedure to ensure compliance with the requirements of the EU EMC Directive.
Conformity assessment is carried out using the manufacturer's own internal production control procedures, detailed in Annex II and Annex III of the EU EMC Directive
The EU EMC Directive does not require the involvement of a Notified Body, however, the manufacturer or its authorized representative in the EU can submit technical documentation to a Notified Body, which will review it and assess whether the technical documentation correctly indicates that the requirements of the EU EMC Directive have been met. At this point, the Notified Body will issue a statement to confirm this, which should be part of the technical file.

Create technical documentation

The manufacturer must establish technical documentation which should be able to assess whether the equipment complies with the relevant requirements and should include an adequate analysis and assessment of the risks. The technical documentation should specify the applicable requirements and, as far as possible, cover the design, manufacture, and operation of the equipment relevant to the assessment. The technical documentation shall contain at least the contents specified in Annex II of the EU EMC Directive, where applicable.

Drafting and signing the EU Declaration of Conformity

When the equipment complies with the applicable requirements, the manufacturer shall draw up and sign the EU Declaration of Conformity and affix the CE marking.
The EU Declaration of Conformity should indicate that the essential requirements set out in Annex I of the EU EMC Directive have been demonstrated to be met.
The EU Declaration of Conformity shall have the model structure as specified in Annex IV of the EU EMC Directive, shall contain the elements specified in the relevant modules as specified in Annexes II and III, and shall be continuously updated.
The EU Declaration of Conformity should be translated into one or more languages required by the Member State where the device is placed on the market.
If the equipment is regulated by more than one EU legislation requiring an EU Declaration of Conformity, one EU Declaration of Conformity should be drawn up for all of these EU legislations.

File Saving

After the device is placed on the market, the manufacturer must keep the technical documentation and the EU Declaration of Conformity for 10 years.
Upon reasonable request from a national competent authority, the manufacturer shall provide that authority with all necessary information and documents, in paper or electronic form, required to demonstrate the conformity of the equipment in a language that can be easily understood by that authority.

CE marking

Equipment must be CE marked before it can be placed on the market.
The CE marking shall be clearly visible and indelibly affixed to the equipment or its nameplate. If affixing the CE marking is not possible or warranted due to the nature of the equipment, it should be affixed to the packaging and accompanying documents.

Labels and information

The equipment should be marked with the manufacturer's name, registered trade name or registered trademark and a contact postal address or, if this is not possible, on the packaging or accompanying documents. The manufacturer's address should indicate a single address where the manufacturer can be contacted. Contact details should be provided in a language that is easily understandable to end users and market surveillance authorities.
The equipment should be marked with the name, registered trade name or registered trademark of the manufacturer or importer and the contact postal address. If this is not possible, it should be indicated on the packaging or accompanying documents. Contact details should be provided in a language that is easily understandable to end users and market surveillance authorities.
Equipment should be marked with type, batch, serial number or other identifiable element, or, when the size or nature of the equipment does not permit, on the packaging or accompanying documents.
The equipment should be accompanied by instructions and information on the use of the equipment as referred to in Article 18 of the EU EMC Directive, in a language that is easy for consumers and other end users to understand, the specific language being determined by the relevant Member State. Such instructions and information and any labeling shall be clear, understandable and easily understood.

Monitoring and reporting

If a manufacturer considers or has reason to believe that a device it has placed on the market does not comply with the EU EMC Directive, it shall immediately take the necessary corrective measures to bring the device into compliance with the EU EMC Directive and, where appropriate, withdraw or recall the device.
If the device presents a risk, the manufacturer shall immediately notify the competent national authorities of the Member States where it has placed the device on the market, detailing the non-compliance and any corrective measures taken.
Manufacturers should cooperate with the competent authorities in taking all measures to eliminate the risks posed by the equipment they put on the market in accordance with their requirements.

Product Statement

Do not make false or misleading statements
The CE mark shall not be affixed to goods that do not fall within the scope of labeling regulations. The CE mark does not indicate that the goods have obtained safety certification from the EU or other institutions, nor does it indicate the origin of the goods. See CE marking guidelines.

EU RED Directive

Directive 2014/53/EU (EU Radio Equipment Directive, EU RED Directive) is used to regulate radio equipment, standardize the safety and electromagnetic compatibility of radio equipment, and promote the protection of the radio spectrum. The EU RED Directive requires that equipment placed on the market meet a high level of safety (protecting the health and safety of people and domestic animals and protecting property), have adequate electromagnetic compatibility, and operate in a manner that promotes efficient use of the radio spectrum and avoids harmful interference.

Sellers are responsible for complying with the EU RED Directive and other applicable laws and regulations, and must also comply with the laws and regulations of applicable EU member states.

If you supply goods to the UK, you must comply with the requirements of the UK Radio Equipment Regulations, which apply throughout the UK, but some of the provisions apply differently in Northern Ireland under the terms of the Windsor Framework. For more information, see the regulatory guidance on supplying equipment into or into the UK, the regulatory guidance on supplying equipment in or into Northern Ireland and the Guidance on Radio Equipment Regulations Regulation 14.

Definition and Classification

According to the EU RED Directive, radio equipment covers almost all devices that use the radio spectrum (such as mobile phones, door openers or broadcast transmitters) but does not apply to devices listed in Annex I.

Compliance Inspection Project Examples

Basic Requirements Manufacturers

Should ensure that the equipment they design and manufacture complies with the essential requirements set out in Article 3 of the EU RED Directive.

Quality System

Manufacturers should ensure that procedures are in place so that serial production complies with the requirements of the EU RED Directive.

Conformity Assessment

Conformity Assessment Procedures

Equipment must undergo an appropriate conformity assessment procedure to ensure compliance with the requirements of the EU RED Directive.
Manufacturers should carry out conformity assessment of radio equipment. Whether the involvement of a notified body is required depends on the conformity assessment procedure adopted. Article 17 of the EU RED Directive sets out the applicable conformity assessment procedures.

Create technical documentation

The manufacturer must establish a technical file, which shall contain detailed information on all relevant data or methods used by the manufacturer to ensure that the radio equipment complies with the essential requirements set out in Article 3 of the EU RED Directive. It shall contain at least the elements listed in Annex V.
Technical documentation and correspondence relating to any EU type-examination procedure shall be drawn up in an official language of the Member State in which the notified body is established or in a language acceptable to that body.

Drafting and signing the EU Declaration of Conformity

When the equipment complies with the applicable requirements, the manufacturer shall draw up and sign the EU Declaration of Conformity and affix the CE marking.
The EU Declaration of Conformity should indicate that the essential requirements set out in Article 3 of the EU RED Directive have been demonstrated to be met.
The EU Declaration of Conformity should have the model structure and elements specified in Annex VI of the EU RED Directive. The simplified EU Declaration of Conformity should contain the elements specified in Annex VII and be continuously updated.
The EU Declaration of Conformity should be translated into one or more languages required by the Member State where the device is placed on the market.
Each radio equipment shall be accompanied by an EU Declaration of Conformity or a simplified EU Declaration of Conformity. If a simplified EU Declaration of Conformity is provided, the exact internet address where the full EU Declaration of Conformity can be obtained.
If the equipment is regulated by more than one EU legislation requiring an EU Declaration of Conformity, one EU Declaration of Conformity should be drawn up for all of these EU legislations.

File Saving

After the device is placed on the market, the manufacturer must keep the technical documentation and the EU Declaration of Conformity for 10 years.
Upon reasonable request from a national competent authority, the manufacturer shall provide that authority with all necessary information and documents, in paper or electronic form, required to demonstrate the conformity of the equipment in a language that can be easily understood by that authority.

CE marking

Equipment must be CE marked before it can be placed on the market.
The CE marking shall be clearly visible and indelibly affixed to the radio equipment or to its nameplate, unless the nature of the radio equipment does not permit or cannot be guaranteed. The CE mark should also be clearly and visibly affixed to the packaging.
Where applicable, the CE marking should be followed by the identification number of the notified body.

Labels and information

The equipment shall be marked with the manufacturer's name, registered trade name or registered trademark and the contact postal address, or, if the size or nature of the radio equipment does not permit, on the packaging or in accompanying documents. The manufacturer's address should indicate a single address where the manufacturer can be contacted. Contact details should be provided in a language that is easily understandable to end users and market surveillance authorities.
The equipment should be marked with the name, registered trade name or registered trademark and the contact postal address of the importer or, if this is not possible, on the packaging or accompanying documents. This includes situations where the size of the radio equipment does not allow this, or where the importer must open the packaging to mark its name and address on the radio equipment. Contact details should be provided in a language that is easily understandable to end users and market surveillance authorities.
Equipment should be marked with type, batch, serial number or other identifiable element, or, when the size or nature of the radio equipment does not permit, on the packaging or in accompanying documents.
The device should be accompanied by instructions and safety information in accordance with Article 8 of the EU RED Directive in a language that is easy for consumers and other end users to understand. The specific language is determined by the relevant Member State. Such instructions and safety information and any labeling should be clear, understandable and easily understood.

Monitoring and reporting

If a manufacturer believes or has reason to believe that a device it has placed on the market does not comply with the EU RED Directive, it shall immediately take the necessary corrective measures to bring the device into compliance with the EU RED Directive and, where appropriate, withdraw or recall the device.
If the device presents a risk, the manufacturer shall immediately notify the competent national authorities of the Member States where it has placed the device on the market, detailing the non-compliance and any corrective measures taken.
Manufacturers should cooperate with the competent authorities in taking all measures to eliminate the risks posed by the equipment they put on the market in accordance with their requirements.

Product Statement

Do not make false or misleading statements
The CE mark shall not be affixed to goods that do not fall within the scope of labeling regulations. The CE mark does not indicate that the goods have obtained safety certification from the EU or other institutions, nor does it indicate the origin of the goods. See CE marking guidelines.

EU Ecodesign Directive and Energy Labeling Regulation

Directive 2009/125/EC (EU Ecodesign Directive) is a framework directive that sets out ecodesign requirements related to environmental parameters. Manufacturers of energy-related products are obliged to design their products according to this framework to improve energy efficiency and reduce other negative environmental impacts throughout the product life cycle. Manufacturers must meet these requirements in order for their products to carry the CE mark.

Regulation (EU) 2017/1369 (EU Energy Labeling Regulation) establishes a framework for energy labeling, requiring that information related to energy efficiency, energy consumption and other resource consumption be provided on product labels, providing users and consumers with the necessary information for purchasing decisions, so as to guide and help consumers choose energy-efficient products and reduce energy consumption.

In addition to the requirement to provide energy labels, suppliers [manufacturers, importers or authorized representatives established in the EU and EEA (Norway, Iceland and Liechtenstein)] must register any products falling within the scope of the EU Energy Labeling Regulation with the European Product Registry for Energy Labelling (EPREL) before placing such models on the EU market. From the date announced as the "date of placement on the market", the model registration will be made available in the public database EPREL. Suppliers should indicate in the database when it no longer places units of a model on the market. Suppliers should ensure that each product unit placed on the EU market is accompanied by an accurately printed label in compliance with the EU Energy Labeling Regulation and related delegated acts. Once all relevant parameter values have been entered, EPREL can generate the label. EPREL also automatically generates product information sheets in all official EU languages. Users can retrieve the label and all public information, including the product information sheet (in any language) from EPREL by searching for the model in EPREL or scanning the QR code on the printed label. For more information, see What Do Suppliers Need to Know?

Suppliers have specific obligations in relation to the EU Energy Labeling Regulation as product labels are intended for end users and are intended to guide purchasing choices. Therefore, suppliers are key players in the implementation of the policy and must convey the information by clearly displaying the energy label when selling the product, and must provide relevant supplementary information, namely the information contained in the "Product Information Sheet" or "Product Manual". Suppliers are obliged to provide product energy efficiency information, which covers not only traditional physical stores, but also online stores, distance sales, catalogs and promotional materials. For example, all European online stores must display label information near the price indication or "Buy" button. For more information, see What Do Dealers Need to Know?

Products covered by the EU Ecodesign Directive and the Energy Labeling Regulation can be found in the product list. For more information, see Ecodesign and Energy Label, Sustainable Product Policy and Ecodesign.

Sellers are responsible for complying with the EU Ecodesign Directive and Energy Labeling Regulation and other applicable laws and regulations, and must also comply with the laws and regulations of applicable EU member states.

In the UK, the Ecodesign of Energy-related Products Regulations (Amendment) and the Energy Information Regulations (Amendment) are the foundational legislation. However, there are differences in how they apply in the United Kingdom (England, Scotland and Wales) and Northern Ireland, for more information see the Regulations: ecodesign of energy-consuming products, Regulations: energy information.

EU RoHS Directive and WEEE Directive

Directive 2011/65/EU (EU Restriction of Hazardous Substances Directive, EU RoHS Directive) restricts the use of certain hazardous substances in electrical and electronic equipment (EEE) and aims to promote the environmentally friendly recycling and treatment of waste electrical and electronic equipment (WEEE). At the same time, Directive 2012/19/EU (EU Waste Electrical and Electronic Equipment Directive, EU WEEE Directive) promotes the collection and recycling of such equipment.

Substances currently restricted by the EU RoHS Directive include: lead (Pb), mercury (Hg), cadmium (Cd), hexavalent chromium (CrVI), polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), di (2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and di-isobutyl phthalate (DIBP). Unless specifically excluded, all products containing electrical and electronic components are subject to these restrictions.

According to the EU RoHS Directive, manufacturers must ensure that the restricted substances contained in EEE do not exceed the maximum concentration values listed in Annex II (each restricted substance shall not exceed 0.1% by weight, except cadmium, which shall not exceed 0.01%).

After ensuring compliance with the provisions of the EU RoHS Directive (through technical documentation and internal production controls), manufacturers must also prepare the EU Declaration of Conformity and affix the CE marking to the finished product and packaging. Manufacturers must keep the EU Declaration of Conformity and technical documentation for 10 years from when the EEE is initially placed on the EU market. Manufacturers and importers need to indicate their name, registered trade name or registered trademark, and contact address on the EEE. Manufacturers must also indicate the type, batch, serial number or other identifiable elements on the EEE. If a manufacturer believes or has reason to believe that the EEE it has placed on the market does not comply with the EU RoHS Directive, it should immediately take necessary corrective measures, including withdrawing or recalling the product where appropriate, and inform the competent authorities of the countries/regions where the EEE is sold.

For more information, see RoHS Directive and WEEE Directive.

Sellers are responsible for complying with the EU RoHS Directive and WEEE Directive and other applicable laws and regulations, and must also comply with the laws and regulations of applicable EU member states.

In the UK, the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (Amendment) Regulations (UK RoHS Regulations) are the underlying legislation. However, there are differences in how they apply in the United Kingdom (England, Scotland and Wales) and Northern Ireland, please refer to the RoHS Regulation Guidance for more information.

France’s AGEC Law and the Restorability Index

The French Law Against Waste and Circular Economy (AGEC Law) aims to increase manufacturers’ commitment to sustainability and better inform consumers about the sustainability of the goods they buy.

According to the AGEC Act, some electrical and electronic equipment must be labeled with a repairability index, which should be affixed to the product or its packaging. In the store, it must be displayed on or near the device. On the Internet, it must be shown in the description of the device near the price.

For more information on the French Repairability Index label, see Everything You Need to Know About the Repairability Index.

Children's Products

IMPORTANT: If sellers list and sell products on Temu, they must comply with all applicable laws, regulations, industry standards, and safety standards, and all Temu policies related to those products, even if the product is not specifically described in our policies.

U.S. Market

Applicable laws and regulations

In the United States, children's products are regulated by the U.S. Consumer Product Safety Commission (CPSC). If the products released and sold in the United States are children's products, sellers should consult the Consumer Product Safety Act (CPSA) and the Consumer Product Safety Improvement Act (CPSIA) and other applicable laws and regulations, and comply with a series of federal safety rules (Children's Product Safety Rules) to ensure that the products released and sold comply with applicable laws and regulations and CPSC requirements. For more information, see Children's Products and the list of Rules Requiring Third-Party Testing and a Children's Product Certificate (CPC).

Definition and classification

The CPSIA defines the term "children's product". Children's products are consumer products designed or intended primarily for children 12 years of age or younger. In determining whether a consumer product is primarily directed to children 12 years of age or younger, the following factors will be considered:

The manufacturer's statement about the product's intended use, including the label on the product (if the statement is reasonable)
Is the product's packaging, display, promotion or advertising suitable for children aged 12 or under?
Is the product generally recognized by consumers as suitable for children aged 12 or below?
The January 2020 Age Determination Guidelines issued by CPSC staff and any subsequent versions of that guidance

Compliance Check Examples

Children's Product Certificate (CPC) and test reports

Children's products subject to the Children's Product Safety Rules must demonstrate compliance with applicable safety requirements in a written Children's Product Certificate (CPC) based on compliance testing results from a CPSC-accepted laboratory.
CPC and test reports must be in English.

Labels and information

Tracking Label

All children's products must have a legible, permanent mark (a "tracking label") that is permanently affixed to the product and product packaging, is legible, and must provide certain identifying information. For more information, see Tracking Label Requirements for Children’s Products

Labels and Consumer Registration Cards for Durable Infant and Toddler Products

Durable infant or toddler products require additional product and packaging labeling and a consumer registration card. For more information, see Labeling Requirements for Durable Infant or Toddler Products and Registration Forms Business Guidance.

Warnings and Instructions

Children's toys and games should carry an appropriate warning statement about choking hazards on the packaging or in specific advertisements. These warning statements must appear in applicable internet advertisements, including on all applicable product detail pages. Age ratings and warning statements on products must be reasonably consistent with the intended use of the product. If a product has characteristics that attract children under 3 years of age to play with it, it cannot be marked as "not suitable for children under 3 years of age" and cannot be used as a way to evade applicable safety requirements. For more information, see the Small Parts and Choking Hazard Labeling FAQs

Examples of compliance Checks on children's toys and games

Title 16 of the Code of Federal Regulations (CFR) Part 1307 Phthalates
Title 16 of the Code of Federal Regulations (CFR) Part 1303 Lead in Paint and Similar Surface Coatings
Title 16 of the Code of Federal Regulations (CFR) Part 1501 Small Parts
Title 16 of the Code of Federal Regulations (CFR) Part 1250 Toys (mandating the use of ASTM F963 safety standards for toys)
Title 16 of the Code of Federal Regulations (CFR) Part 1505 Electric Toys or Articles
Tracking Labels
Age Grading and Appropriate Warnings and Instructions

For more information, see the Phthalates Business Guidance and Lead in Paint.

EU and UK Market

Applicable laws and regulations

Directive 2009/48/EC (EU Toy Safety Directive), applicable laws and regulations for the EU and UK markets, lists the provisions for the supply and sale of toy products in the EU, including a series of important requirements such as toy safety requirements, conformity assessment, labeling, and warnings.

Sellers are responsible for complying with the EU Toy Safety Directive and other applicable laws and regulations, and must also comply with the laws and regulations of applicable EU member states.

If sellers supply goods to the UK, they must comply with the requirements of the UK Toys (Safety) Regulations, which apply throughout the UK, but some of the provisions apply differently in Northern Ireland under the terms of the Windsor Framework. For more information, see the Toys (Safety) Regulations: Great Britain and Toys (Safety) Regulations: Northern Ireland.

Definition and Classification

According to the EU Toy Safety Directive, a toy is any product or material designed or intended for children under 14 years of age to play with, whether or not it is specifically intended for children to play with. Any product that is designed to have potential play functionality, is attractive to children, or is marketed to children may be considered a toy within the scope of the EU Toy Safety Directive. However, some product types are excluded. For a complete list of exclusions, please refer to Annex I of the EU Toy Safety Directive. For information on whether certain borderline products are toys, please refer to the Guidance on Toy Safety.

Compliance check example(s)

Safety requirements.

Toys must comply with the essential safety requirements listed in Annex II of the EU Toy Safety Directive (see Toy Safety in the EU), for example:

General risks: health and safety of children and other people such as parents or caregivers.
Special risks: physical and mechanical risks, flammability risks, chemical risks, electrical risks, hygiene risks and radioactive risks.

Toys (including the chemicals they contain) must not endanger the health and safety of people when used in a foreseeable way.

In general, substances that are carcinogenic, mutagenic or reprotoxic (CMR substances) are not allowed to be in accessible parts of toys.
In addition to specified restrictions, 19 "heavy elements", such as mercury and cadmium, must not be present in child-accessible parts of toys.
Some allergenic fragrances are banned, while others may be used in certain toys if they are indicated on the label and meet additional requirements.

There are specific requirements for toys intended for children under 36 months or other children of other specific age groups. For example, toys intended for children under 36 months must not contain small parts or certain chemical substances.

Quality system.

The manufacturer should ensure that procedures are in place for series production to comply with the requirements of the EU Toy Safety Directive.

Conformity assessment.

Conformity assessment procedures.

Toys must undergo an appropriate conformity assessment procedure to ensure compliance with the requirements of the EU Toy Safety Directive.
Manufacturers must carry out an individual safety assessment of their toys.
If the toy is not fully (or partially) covered by the harmonized standards set out in Article 13 of the EU Toy Safety Directive, or if the manufacturer believes that the toy requires verification by a notified body (NANDO), it must be submitted to the notified body for EC type examination.

Establishment of technical documentation.

The manufacturer must establish technical documentation, which should contain details of all relevant data or methods used by the manufacturer to ensure that the toy conforms to the requirements, and should, in particular, include the documents listed in Annex IV of the EU Toy Safety Directive.
The technical documentation should be drawn up in one of the official languages of the European Union, and, upon reasoned request by a Member State market surveillance authority, the manufacturer should translate the relevant parts of the technical documentation into the language of that Member State.

Drafting and signing of the EU Declaration of Conformity.

When a toy complies with the applicable safety requirements, the manufacturer shall draw up and sign the EU Declaration of Conformity and affix the CE marking.
The EU Declaration of Conformity shall indicate that compliance with the requirements set out in Article 10 and Annex II of the EU Toy Safety Directive has been demonstrated.
The EU Declaration of Conformity shall contain at least the elements and model structure set out in Annex III of the EU Toy Safety Directive and the relevant modules set out in Annex II of Decision No 768/2008/EC, and shall be continuously updated.
The EU Declaration of Conformity shall be translated into one or more languages required by the Member States where the toy is placed on the market or sold.

Document retention.

After the toy is placed on the market, the manufacturer shall keep the technical documentation and the EU Declaration of Conformity for 10 years.
Upon reasonable request from a national competent authority, the manufacturer shall provide all the information and documents necessary to demonstrate that the toy complies with the requirements in a language easily understood by said competent authority.

Affixing CE marking.

Toys must be affixed with the CE marking before they are placed on the market.
The CE marking must be clearly visible and indelibly affixed to the toy, label, or packaging. For small toys and toys consisting of small parts, the CE mark can also be affixed to the label or accompanying instructions. If the CE marking is not visible from the outside of the packaging, it should at least be affixed to the packaging.

Labels and information.

Toys should be marked with the manufacturer's name, registered trade name, or registered trademark and contact address. If this is not possible, it should be marked on the toy packaging or in the documents accompanying the toy. • The manufacturer’s address should indicate a single place where the manufacturer can be contacted.
Toys should be marked with the importer’s name, registered trade name, or registered trademark and a contact address, or, if this is not possible, on the toy packaging or in the documentation accompanying the toy.
Toys should be marked with the type, batch, serial number, model or other identifiable element, or, where the size or nature of the toy does not permit, on the toy packaging or in the documentation accompanying the toy.
Toys should be accompanied by instructions and safety information in a language or languages that are easily understood by consumers, with the specific languages to be determined by the Member State concerned.

For example: warnings that determine whether or not to buy a toy, such as warnings setting out the minimum and maximum ages of users, and other applicable warnings listed in Annex V to the EU Toy Safety Directive, should appear on the consumer packaging or otherwise be clearly visible to the consumer before purchase, including if purchased online.

Monitoring and reporting.

If a manufacturer considers or has reason to believe that a toy it has placed on the market does not comply with the EU Toy Safety Directive, it should immediately take the necessary corrective action to bring the toy into compliance, and where appropriate, withdraw or recall it.
If a toy presents a risk, the manufacturer shall immediately notify the competent national authority of the Member State in which the toy is manufactured with details of the non-compliance and any corrective action taken.
Manufacturers shall, upon their request, cooperate with the competent authorities in taking all measures to eliminate the risks posed by the toys they place on the market.

Product declarations.

No false or misleading statements shall be made.
The CE mark shall not be affixed to goods that do not fall within the scope of the labeling regulations. The CE mark does not indicate that the product has been certified for safety by the EU or other bodies, nor does it indicate the product's place of origin. See CE Marking Guidance and CE Marking for the Toy Industry.

General Product Safety Directive (GPSD) and General Product Safety Regulation (GPSR)

In addition to the EU Toy Safety Directive, childcare articles should comply with the requirements of Directive 2001/95/EC (EU General Product Safety Directive, GPSD) and Directive 87/357/EEC (EU Food Simulants Directive).

Based on GPSD, the European Commission has formulated: Decision 2010/9/EU on the safety requirements of infant bath rings, bathing aids, bathtubs, and bathtub stands that must comply with European standards; Decision 2010/376/EU on the safety requirements of certain products in children's sleeping environments that must comply with European standards; Decision 2013/121/EU on the safety requirements of certain child seats that must comply with European standards; Decision (EU) 2023/1338 on the safety requirements of certain children's products and related products that must comply with European standards, etc.

In addition, some products that look like food may be harmful to children. The EU Food Simulants Directive prohibits the production, import and sale of non-edible products that look like food, such as soaps, candles and other decorative items. For more information, please refer to the standards and risks for specific products.

From December 13, 2024, Regulation (EU) 2023/988 (EU General Product Safety Regulation, GPSR) will replace the current GPSD and the EU Food Simulants Directive. Please refer to the General Product Safety Regulation.

Personal Protective Equipment

US Market

Personal protective equipment, commonly referred to as "PPE", is equipment worn to minimize exposure to hazards that lead to serious workplace injuries and illnesses. These injuries and illnesses may result from exposure to chemical, radiological, physical, electrical, mechanical, or other workplace hazards. PPE may include items such as gloves, safety glasses and shoes, ear plugs or earmuffs, hard hats, respirators, or coveralls, vests, and full-body suits.

The Occupational Safety and Health Administration (OSHA) of the US Department of Labor has established standards and requirements for personal protective equipment for general industry, the shipyard industry, the shipping industry, port operations, and the construction industry. These standards and requirements are respectively contained in Chapter 29 of the Code of Federal Regulations (CFR):

Part 1910, Subpart I, Personal Protective Equipment for General Industrial Industries
Part 1915, Subpart I, Personal Protective Equipment for Shipyard Industries
Part 1917, Subpart E, Personal Protection for Shipping Terminals
Part 1918, Subpart J, Personal Protective Equipment for Port Operations
Part 1926, Subpart E, Personal Protective and Lifesaving Equipment for the Construction Industry

OSHA requires that many categories of personal protective equipment must conform to or be equivalent to standards established by the American National Standards Institute (ANSI).

Examples of OSHA standards for personal protective equipment in general industry:

1910.133 Eye and face protection

1910.134 Respiratory protection

1910.135 Head protection

1910.136 Foot protection

1910.137 Electrical protective equipment

1910.138 Hand protection

1910.140 Personal fall protection systems

Examples of OSHA standards for personal protective equipment in the shipyard industry:

1915.153 Eye and face protection

1915.154 Respiratory protection

1915.155 Head protection

1915.156 Foot protection

1915.157 Hand and body protection

1915.158 Lifesaving equipment

1915.159 Personal fall arrest systems

1915.160 Positioning device systems

Examples of OSHA standards for protective equipment at shipping terminals:

1917.92 Respiratory protection

1917.93 Head protection

1917.94 Foot protection

1917.95 Other protective measures

Examples of OSHA standards for personal protective equipment for port operations:

1918.101 Eye and face protection

1918.102 Respiratory protection

1918.103 Head protection

1918.104 Foot protection

1918.105 Other protective measures

For more information on OSHA standards, see:

National Institute for Occupational Safety and Health (NIOSH) and Respirators

Respirators protect the wearer in two basic ways. The first is to remove pollutants from the air. This type of respirator includes particulate respirators, which filter particles from the air. The other is a "gas mask", which filters out chemicals and gases. Other respirators protect the user by providing clean breathable air from another source. Respirators in this category include aviation respirators and self-contained breathing apparatus (SCBA).

The mission of the National Institute for Occupational Safety and Health (NIOSH) Personal Protective Technology (PPT) Program is to prevent work-related injuries, illnesses, and fatalities by increasing the knowledge and application of PPT. In this context, PPT is defined as technical methods (e.g., fit testing methods), processes, techniques, tools, and materials that support the development and use of personal protective equipment (PPE) worn by individuals to reduce their exposure to hazardous effects. For more information, see the NIOSH Personal Protective Equipment Catalog.

The PPT program is responsible for testing and approving new respirators before they enter the market. NIOSH approves respirators under Title 42 of Code of Federal Regulations (CFR) Part 84, which ensures that NIOSH-approved respirators meet minimum standards of construction, performance, and respiratory protection to keep users safe.

NIOSH has registered several respirator-specific certification marks on behalf of the US Department of Health and Human Services (HHS). These registered certification marks include the NIOSH stylized mark, NIOSH Approved, and certification marks (for example, N95, N99, N100, R95, P95, P99, P100). Only manufacturers approved by NIOSH may use these registered certification marks. You can find NIOSH-approved particulate filtering facepiece respirators on this page. Any misuse of a registered certification mark is in direct violation of applicable trademark laws, and may be subject to enforcement action. For more information, see Counterfeit Respirators/False Statements of NIOSH Approval.

US Consumer Product Safety Commission (CPSC) and bicycle helmets

In accordance with the requirements of the Consumer Product Safety Act (CPSA) and the Consumer Product Safety Improvement Act (CPSIA):

Certain general purpose products that are subject to a similar rule, ban, standard, or regulation under the Consumer Product Safety Rule or any other CPSC-enforced regulation must demonstrate compliance with the applicable safety rule in the form of a written General Certificate of Conformity (GCC). GCC and test reports must be in English.
Children's products subject to federal children's product safety rules must demonstrate compliance with applicable safety rules in the form of a written Children's Product Certificate (CPC) based on test results from a CPSC-accepted laboratory. The CPC and test report must be in English.

A bicycle helmet is any helmet that is marketed as protecting cyclists from head injuries while riding, or is marketed or advertised in a way that implies that it provides such protection. A helmet is still considered a bicycle helmet if it is advertised or represented as providing protection during general use or during various specific uses other than bicycling, and a reasonable consumer could conclude from the marketing or publicity that bicycling is one of the intended uses of the helmet. Bicycle helmets designed primarily for children 12 years of age or younger are considered children's products.

The mandatory rules for adult and children's bicycle helmets are contained in Title 16 of the Code of Federal Regulations (CFR) Part 1203.

For more information, see the list of mandatory rules requiring a General Certificate of Conformity (GCC) and the list of rules requiring third-party testing and a Children's Product Certificate (CPC).

EU and UK Markets

Applicable Laws and Regulations

Regulation (EU) 2016/425 (EU PPE Regulation), applicable to the EU and UK markets, regulates the import and sale of personal protective equipment (PPE) within the EU, including health and safety requirements for the design and manufacture of PPE, labeling requirements, procedures for assessing whether goods comply with these requirements, and obligations of PPE manufacturers, importers and distributors. For more information, see EU PPE.

Sellers are responsible for complying with the EU PPE regulations and other applicable laws and regulations, and must also comply with the laws and regulations of applicable EU member states.

EU PPE regulations became directly applicable in the UK from April 21, 2018, with the enforcement and sanctions regime incorporated into UK law by the Personal Protective Equipment (Enforcement) Regulations (SI 2018 No. 390). The Product Safety and Metrology, etc. (Amendment, etc.) (EU Exit) Regulations fix deficiencies that arose after the UK left the EU (such as references to EU institutions) and set out specific provisions for the UK market. As a result, there is one set of revised UK PPE regulations in the UK, but some of the provisions apply differently in Northern Ireland under the terms of the Windsor Framework. For more information, see the Guidance on the regulations as they apply to personal protective equipment being supplied in or into Great Britain or Guidance on the regulations as they apply to personal protective equipment being sold in or into Northern Ireland.

Definition and Classification

The EU PPE Regulation defines PPE as:

1. Equipment designed and manufactured to protect persons from one or more risks to health or safety.

2. Interchangeable parts of the equipment described in 1. that are essential to its protective function.

3. The connection system of the equipment described in 1., which is not held or worn by persons, is intended to connect the equipment to external equipment or reliable anchor points, is not designed to be permanently fixed, and does not require tightening work before use.

The EU PPE Regulation specifies three risk categories of PPE in Annex I, namely Category I, Category II and Category III. Class I PPE is designed to protect the user from minimal risks. Category III PPE is designed to protect the user from very serious risks. Category II PPE includes PPE not listed in the above two categories.

Compliance Check Example(s)

Health and safety

PPE must comply with the essential health and safety requirements set out in Annex II of the EU PPE Regulation.

Quality systems

The manufacturer should ensure that procedures are in place so that batch production complies with the requirements of the EU PPE Regulation. Manufacturers shall implement an approved quality system in accordance with Point 3 of Annex VIII of the EU PPE Regulation, carry out production, final product inspection, and testing of the relevant PPE, and shall be subject to the supervision provided for in Point 4.

Conformity assessment

Conformity assessment procedures

PPE must undergo an appropriate conformity assessment procedure to ensure compliance with the requirements of the EU PPE Regulation.
Manufacturers shall carry out the applicable conformity assessment procedures or entrust others to do so in accordance with Article 19 of the EU PPE Regulation.
The conformity assessment procedures for Category II and Category III PPE require the participation of a notified body (NANDO).

Establishment of technical documentation

Manufacturers must establish technical documentation, which must be able to assess whether the PPE conforms to the requirements of the EU PPE Regulation. The technical documentation shall specify the methods used by the manufacturer to ensure that the PPE conforms to the applicable essential health and safety requirements, and shall include at least the contents listed in Annex III to the EU PPE Regulation.

The drawing up and signing the EU Declaration of Conformity

When the PPE conforms to the applicable essential health and safety requirements, the manufacturer shall draw up and sign the EU Declaration of Conformity and affix the CE marking.
The EU Declaration of Conformity shall indicate that compliance with the applicable essential health and safety requirements set out in Annex II to the EU PPE Regulation has been demonstrated.
The EU Declaration of Conformity shall have the model structure set out in Annex IX of the EU PPE Regulation, shall contain the elements set out in the relevant modules set out in Annexes IV, VI, VII and VIII, and shall be kept up to date.
The EU Declaration of Conformity shall be translated into the language or languages required by the Member States in which the PPE is placed or sold.
The manufacturer shall provide the EU Declaration of Conformity with the PPE or include the internet address where the EU Declaration of Conformity can be accessed in the instructions and information set out in Point 1.4 of Annex II to the EU PPE Regulation.
If the PPE is subject to more than one EU legislation requiring an EU Declaration of Conformity, one EU Declaration of Conformity shall be drawn up for all of those EU legislations.

Document retention

Manufacturers shall ensure the technical documentation and the EU Declaration of Conformity are the disposal of national authorities for 10 years after the PPE is placed on the market.
Upon the reasonable request of a national authority, the manufacturer shall provide that authority with all necessary information and documents, in paper or electronic form, required to demonstrate conformity of the PPE, in a language easily understood by that authority. The manufacturer's obligations may be fulfilled by their authorized representative in the manufacturer's name and under their responsibility, provided that these obligations are set out in the authorization letter.

Affixing the CE marking

PPE must be CE-marked before being placed on the market.
The CE marking must be clearly visible and indelibly affixed to the PPE. If this is not possible due to the nature of the PPE, it should be affixed to the packaging and accompanying documents.
Where applicable, the CE marking should be followed by the identification number of the notified body.

Labeling and information

PPE should be marked with the manufacturer's name, registered trade name or registered trademark and a contact postal address. If this is not possible, it should be indicated on the packaging or in the documents accompanying the PPE. The address should indicate a single address where the manufacturer can be contacted. Contact details should be provided in a language easily understood by end users and market surveillance authorities.
PPE should be marked with the name, registered trade name, or registered trademark, and a contact postal address for the importer, or, if this is not possible, on the packaging or in the documents accompanying the PPE. Contact details should be available in a language easily understood by end-users and market surveillance authorities.
PPE should be marked with the type, batch, serial number or other identifiable element, or, if the size or nature of the PPE does not permit, on the packaging or in a document accompanying the PPE.
PPE should be accompanied by the instructions and information set out in Point 1.4 of Annex II to the EU PPE Regulation in a language determined by the Member State concerned so as to be easily understood by consumers and other end-users. Such instructions and information, as well as any labeling, shall be clear, understandable, comprehensible and legible.

Monitoring and reporting

If the manufacturer considers or has reason to believe that the PPE it has placed on the market does not comply with the provisions of the EU PPE Regulation, they shall immediately take the necessary corrective measures to bring the PPE into compliance and withdraw or recall it as appropriate.
If the PPE presents a risk, the manufacturer shall immediately notify the national competent authorities of the Member States where they have placed the PPE on the market, detailing the non-compliance and any corrective measures taken.
The manufacturer shall, upon request, cooperate with the competent authorities in taking all measures to eliminate the risks posed by the PPE it has placed on the market.

Product declarations

No false or misleading statements shall be made.
The CE mark shall not be affixed to goods that are not covered by the labeling regulations. The CE mark does not indicate that the goods have been certified for safety by the EU or other bodies, nor does it indicate the origin of the goods. Please refer to the CE marking guidelines.

Vehicle-Related Products

US Market

Applicable Laws and Regulations

In the United States, the National Highway Traffic Safety Administration (NHTSA) regulates the safety of vehicles and related products. NHTSA publishes Federal Motor Vehicle Safety Standards (FMVSS), which can be found in 49 CFR Part 571. NHTSA enacts the Vehicle Safety Act, found at 49 CFR, and the Highway Safety Act, found at 23 CFR. For more information, see NHTSA Laws and Regulations.

Definition and Classification

The Vehicle Safety Act defines motor vehicle equipment as:

Any system, part, or assembly originally manufactured for a motor vehicle;
Any similar part or assembly manufactured or sold as a replacement or improvement to a system, part, or assembly, or as an accessory or add-on to a motor vehicle; or
Any equipment, article, or apparel, including motorcycle helmets, but excluding medications or eyewear prescribed by a licensed physician, that is not a system, part, or assembly of a motor vehicle and that is manufactured, sold, delivered, or offered for sale for use on public streets, roads, and highways for the express purpose of protecting motor vehicle users from the risk of accident, injury, or death.

Compliance Check Example(s)

Under the Vehicle Safety Act, motor vehicle equipment subject to FMVSS manufactured and sold in the United States must be certified to comply with all applicable FMVSS regulations. Motor vehicle equipment that is not subject to FMVSS does not require certification; however, such equipment may be found by NHTSA or the manufacturer to have safety-related defects, in which case the manufacturer is obligated to provide defect notification and remedies to equipment owners.

Motor vehicle equipment subject to FMVSS includes:

Tires: FMVSS No. 109/110/117/119/120/129/139. For more information, see Tires.
Rims: FMVSS No. 110/120.
Brake hoses: FMVSS No. 106.
Brake fluid: FMVSS No. 116.
Seat belt assemblies: FMVSS No. 209.
Lights, reflectors, and related equipment: FMVSS No. 108.
Glazing (automotive glass and plastics): FMVSS No. 205.
Motorcycle helmets: FMVSS No. 218.
Child restraint systems (child safety seats): FMVSS No. 213. For more information, see Car Seats and Booster Seats.
Platform lift systems for people with reduced mobility: FMVSS No. 404.
Rear impact guard for trailers: FMVSS No. 223.
Reflective warning triangles: FMVSS No. 125.
Compressed Natural Gas Containers: FMVSS No. 304.

For more information, see Requirements for Manufacturers of Motor Vehicles and Motor Vehicle Equipment.

Emissions Requirements

The US Environmental Protection Agency (EPA) regulates air pollution emissions from mobile and stationary sources under the Clean Air Act (CAA). The CAA requires that new engines and equipment sold or distributed in the United States must be certified to meet emission requirements established by the EPA to protect public health and the environment from air pollution. The CAA and its implementing regulations also contain various requirements regarding testing, reporting, record keeping, warranty, labeling, tampering, defeat devices, and vehicle and engine maintenance and modifications. For more information, see Air Enforcement.

California Vehicle Code Section 27156 prohibits modifications that increase motor vehicle emissions. For products subject to the California Vehicle Code, such as engines, aftermarket auto parts, catalytic converters, air purifiers, consumer products, and gas tanks, their product information should include the corresponding Executive Order (EO) number or certification that allows them to be sold into California. For more information, see the California Air Resources Board (CARB).

Portable Fuel Containers

Requirements for portable fuel containers vary depending on the fuel and container type.

Portable Gasoline, Kerosene, and Diesel Containers

The Children’s Gasoline Burn Prevention Act (CGBPA), enacted in 2008 and amended by the Portable Fuel Container Safety Act (PFSCA) of 2020, requires portable gasoline, kerosene, and diesel containers to comply with the ASTM F2517 standard. These requirements are codified in Title 16 of Code of Federal Regulations (CFR) Part 1460.

Portable Fuel Containers

The PFCSA also requires portable fuel containers to be equipped with flame mitigation devices to stop the spread of flames into the container. Title 16 of the Code of Federal Regulations (CFR) Part 1461 states:

Pre-filled portable fuel containers: must comply with ASTM F3429/F3429M-24.
Empty portable fuel containers: must comply with ASTM F3326-21.
Safety cans: must comply with UL 30:2022.

Packaging

Certain liquid fuels are listed in Title 16 of the Code of Federal Regulations (CFR) Part 1700, which must be packaged in special packaging in accordance with the Poison Prevention Packaging Act (PPPA).

Labeling

Manufacturers and importers of portable containers intended for filling with gasoline, kerosene, or other petroleum distillates should review the labeling requirements of Title 16 CFR Section 1500.

Certification

Under the requirements of the Consumer Product Safety Act (CPSA) and the Consumer Product Safety Improvement Act (CPSIA), certain general purpose products that are subject to a similar rule, ban, standard, or regulation under the Consumer Product Safety Rule or any other CPSC-enforced regulation must demonstrate compliance with the applicable safety rule in the form of a written General Certificate of Conformity (GCC). GCC and test reports must be in English.

Some mandatory rules regarding portable fuel containers are found in:

16 CFR Part 1461 Portable Fuel Containers (Flame Mitigation Devices)
16 CFR Part 1460 Portable Fuel Containers (Special Packaging)
16 CFR Part 1700 Special Packaging (PPPA)

For more information, see the Portable Fuel Container Business Guidance and the Rule Requiring a General Certificate of Conformity (GCC).

In addition, Title 40 Code of Federal Regulations (CFR) Part 59, Subpart F, regulates the control of evaporative emissions from new and in-use portable fuel containers. Portable fuel containers advertised and sold by sellers must be EPA certified and obtain a certificate of conformity. For more information, see Certification for Portable Fuel Containers.

EU and UK Market

Summary of EU Motor Vehicle Legislation

Motor vehicles and their trailers, systems, and components

Directives and regulations on motor vehicles, their trailers, systems, and components
Regulation (EU) 2018/858 on the approval and market surveillance of motor vehicles and their trailers and of systems, components, and separate technical units intended for such vehicles

Two- and three-wheel vehicles and quadricycles

Directives and regulations on two- and three-wheel vehicles and quadricycles two-, three- and four-wheelers
Regulation (EU) No 168/2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles

Tractors

Directive and regulations regarding tractors
Regulation (EU) No 167/2013 on the approval and market surveillance of agricultural and forestry vehicles

Emissions from non-road mobile machinery.

Emissions regulations for non-road mobile machinery
Regulation (EU) 2016/1628 on emission limits and type-approval requirements for gaseous and particulate pollutants from internal combustion engines for non-road mobile machinery.

United Nations Economic Commission for Europe (UNECE) regulations.

UNECE legislation aims to establish a global automotive market while ensuring a high level of environmental protection and safety. Common technical requirements, such as those set out by UNECE, can reduce development costs and avoid duplication of administrative procedures. They are also an important tool for avoiding technical barriers to trade. Refer to the United Nations Economic Commission for Europe (UNECE) regulations and international technical harmonization.

Definitions and Classifications

The main categories of vehicles are:

Class M: Passenger vehicles
Class N: Cargo vehicles
Class L: Two-wheelers, three-wheelers and four-wheelers
Class T: Agricultural and forestry tractors and their trailers

Vehicles belonging to Class M or Class N are classified as follows:

Light vehicles (passenger cars and vans), or
Heavy vehicles (trucks, buses and coaches)

For more information, see Vehicle Categories.

Type Approval

Type approval is the process used by national authorities to certify that a vehicle model complies with all EU safety, environmental, and production conformity requirements before authorizing it to be placed on the EU market.

The type approval authority (TAA, e.g. the German Federal Road Traffic Authority (KBA)) is responsible for the formal approval of vehicles before they are placed on the EU market. The decision on approval is based on compliance tests, which are performed by testing agencies and laboratories (technical service agencies, in most cases specially designated by the TAA).

Manufacturers offer about a dozen pre-production cars that are identical to the final product. The prototypes are used to test compliance with EU safety rules (lighting installation, braking performance, stability control, crash tests with dummies), noise and emission limits, and production requirements (individual components such as seat or steering wheel airbags). If all relevant requirements are met, the national competent authority will issue an EU vehicle type-approval to the manufacturer, authorizing the sale of the vehicle model in the EU.

Every vehicle is accompanied by a Certificate of Conformity (CoC), which is a declaration from the manufacturer that the vehicle complies with EU type-approval requirements.

EU countries establish or appoint market surveillance authorities and notify the Commission accordingly. Market surveillance authorities ensure that vehicles, systems, components, and separate technical units (including spare parts and equipment) placed on the market comply with the requirements of EU harmonization legislation. Market surveillance authorities also ensure that vehicles and their components do not endanger health, safety, the environment, or any other aspect of public interest protection.

The EU Tire Labeling Regulation

Regulation (EU) 2020/740 (EU Tire Labeling Regulation) establishes a framework to provide uniform tire parameter information through labeling, enabling end users to make informed choices when purchasing tires. The purpose is to improve safety, protect health, and improve the economic and environmental efficiency of road transport by promoting fuel-efficient, durable, low-noise safety tires.

The EU Tire Labeling Regulation requires an energy efficiency label to be affixed to tires and a product information sheet to be provided on the tires. Tire labels highlight the tire's performance in terms of fuel efficiency, safety, and noise, and also indicate whether the tire is suitable for use in heavy snow or other extreme weather conditions. See the Tire Labelling for more information.

For more information on the supply of vehicle-related goods in the EU and UK, see:

Consumer Chemicals

US Market

Toxic Substances Control Act (TSCA)

The Toxic Substances Control Act (TSCA) authorizes the US Environmental Protection Agency (EPA) to regulate the manufacture, processing, distribution, use, sale, and disposal of chemicals to prevent the public from experiencing unreasonable risks of harm to health or the environment. Importers of chemical substances, mixtures, or articles containing chemical substances or mixtures must comply with TSCA before importing these items into the United States.

TSCA covers the production, importation, use, and disposal of certain chemicals, including polychlorinated biphenyls (PCB), asbestos, radon, and lead.

Certain substances are generally excluded from the scope of TSCA, including foods, drugs, cosmetics, and pesticides. Food, drugs, and cosmetics are regulated by the Food, Drug, and Cosmetic Act (FD&C Act). Please visit the US Food and Drug Administration (FDA) page for more information. Pesticides are regulated by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Please visit the US Environmental Protection Agency (EPA) page for more information.

For more information, see the Summary of the Toxic Substances Control Act.

Occupational Safety and Health Administration (OSHA)

In 2003, the United Nations adopted the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). GHS is a standard for classifying health, physical, and environmental hazards, and specifies what information should be included on hazardous chemical labels and safety data sheets.

The Hazard Communication Standard (HCS) issued by the Occupational Safety and Health Administration (OSHA), which is consistent with GHS, requires chemical manufacturers and importers to evaluate the hazards of the chemicals they produce or import and prepare labels and safety data sheet to communicate hazard information to downstream buyers.

Safety Data Sheets

The safety data sheet is a detailed document provided by the manufacturer or importer of a chemical. The safety data sheet contains the following information: the properties of each chemical, the physical, health and environmental hazards, protective measures, and safety precautions for handling, storing and transporting the chemical.

Sellers should provide safety data sheet for the chemicals they sell. Relevant safety data sheets can be obtained from manufacturers or suppliers. If the product is a combination product that contains multiple chemical products, a safety data sheet should be provided for each product in the combination product.

Federal Hazardous Substances Act (FHSA)

The Federal Hazardous Substances Act (FHSA), enacted in 1960, requires cautionary labeling of hazardous substances to help consumers store and use these products safely and provide them with information about emergency first aid measures to take in the event of an accident. For additional information about the Federal Hazardous Substances Act, including the Commission's determination that certain substances are hazardous, see Title 16 Code of Federal Regulations (CFR) Parts 1500-1513.

The FHSA also allows the CPSC to ban certain extremely hazardous household products if label information is not adequate to protect consumers. For more information, see Federal Hazardous Substances Act (FHSA) Requirements.

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Pesticides

The US Environmental Protection Agency (EPA) regulates pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The FIFRA was originally enacted in 1947 and has been amended several times, most recently by the Food Quality Protection Act (FQPA) and the Pesticide Registration Improvement Act (PRIA). Individuals or companies subject to the law are responsible for understanding and complying with FIFRA and all applicable laws and regulations.

For more legal and technical information on how EPA regulates pesticides in the United States, see:

Definition and Classifications

According to FIFRA, a pesticide is any substance or mixture of substances used to prevent, destroy, repel, or mitigate any pest, or used as a plant regulator, defoliant, or desiccant. Title 40 of the Code of Federal Regulations (CFR) Part 152.6 lists substances that are not regulated under FIFRA, provided they meet specified conditions or criteria. Non-pesticide products are listed in 40 Code of Federal Regulations (CFR) Parts 152.8 and 152.10 because they are not intended for use against pests or for insecticidal purposes.

Compliance Check Example(s)

Registrant obligations

Registrants are fully responsible for their pesticides and pesticide labels
Company No.:

A company number is a unique identifier assigned to a company that wishes to register a pesticide with EPA. Registrants must obtain a company number prior to registering their first product. A company number is also required for companies planning to produce pesticides or equipment. This type of production requires the company to obtain a pesticide manufacturing or equipment manufacturing establishment number. The company number is part of the organization number.

Organization Number:

When manufacturing or formulating pesticides, you must register the site (or facility) where the pesticide or equipment is manufactured and obtain an organization number.

For more information on registrant obligations, see:

Pesticide Registration

With exceptions, all pesticides sold in the United States must be registered with the EPA.
Unlike pesticides, if the pest is controlled by physical or mechanical action (rather than a substance), the product is considered a device and does not need to be registered with EPA. However, equipment is also subject to other provisions of the law.
For more information on pesticide registration and equipment obligations, see:

Labels and Information

Pesticide label review is part of the pesticide registration process. Labels on pesticide packages or containers and accompanying instructions are an important part of pesticide regulation. Labels provide important information on how to handle and use pesticide products safely, and on how to avoid harm to human health and the environment. See Labeling Requirements and Pesticide Labels.

Product claims.

“Treatment” generally refers to articles that have been treated with an antimicrobial pesticide to protect the article itself. These treated products often claim to protect the public from harmful microorganisms. These products fall into the regulated categories of implicit or explicit public health pesticide claims. Any pesticide treatment product that is not registered with the EPA cannot make a public health claim, such as “fights bacteria, provides antimicrobial protection, or controls fungi”. For more information, see Consumer Products Treated with Pesticides.
For residual claims, see the Guidance for Products Adding Residual Efficacy Claims.

EU and UK Market

EU REACH Regulation

Regulation (EC) No 1907/2006 (EU Regulation concerning the Registration, Evaluation, Authorization and Restriction of Chemicals, EU REACH Regulation) applies to the sale and safe use of chemicals within the EU, aiming to better protect human health and the environment from the hazards of chemicals while improving the competitiveness of the EU chemical industry. The EU REACH Regulations also advocate the use of alternative methods to assess the hazards of substances in order to reduce the number of animal tests.

EU REACH Regulations involve the registration, evaluation, authorization, and restriction of chemical substances. In principle, the EU REACH Regulations apply to all chemical substances; not only those used in industrial processes, but also those used in everyday life, in items such as cleaners, paints, clothes, furniture, and electrical appliances.

Under the EU REACH Regulations, manufacturers and importers are generally required to collect information on the properties of chemical substances present in their articles and may be subject to registration, authorization, restriction or information provision requirements. In addition, distributors may also need to comply with the EU REACH Regulations and meet information requirements. For more information, see Chemicals Legislation and Understanding REACH.

For more information on selling chemicals in the United Kingdom (England, Scotland, and Wales) and Northern Ireland, see UK Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH).

EU CLP Regulation

Regulation (EC) No 1272/2008 (EU Regulation on Classification, Labeling and Packaging of Substances and Mixtures, EU CLP Regulation) is a supplement to the EU REACH Regulation. The EU CLP Regulation is based on the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS), which aims to ensure a high level of health and environmental protection, as well as the free movement of substances, mixtures, and articles. The EU CLP Regulation requires manufacturers, importers, or downstream users of substances or mixtures to properly classify, label, and package hazardous chemicals before placing them on the market.

Unless otherwise exempted, the EU CLP Regulation applies to all substances and mixtures. For example, pigments, detergents, glues, spray paints, and pesticides are products regulated by the EU CLP Regulations.

One of the main purposes of the EU CLP Regulation is to determine whether a substance or mixture has properties that lead to hazard classification. In this context, classification is the starting point for hazard communication. When relevant information on a substance or mixture (e.g. toxicological data) meets the classification criteria in the EU CLP Regulation, the hazards of the substance or mixture can be identified by assigning specific hazard classes and categories. The hazard categories in the EU CLP Regulation cover physical, health, environmental, and other hazards. Once a substance or mixture has been classified, the identified hazards must be communicated to other actors in the supply chain, including consumers. Hazard labeling allows the hazard classification, labeling, and safety data sheets to be communicated to the users of a substance or mixture to alert them to hazards and the need to manage the associated risks.

The EU CLP Regulation sets detailed standards for label elements: pictograms, signal words, and standard statements of hazard, prevention, response, storage, and disposal for each hazard class and category. It also sets general packaging standards to ensure the safe supply of hazardous substances and mixtures. For more information, see Chemicals Legislation and Understanding CLP.

Furthermore, under the EU CLP Regulation, any advertisement for a product classified as dangerous, or a mixture subject to Article 25(6), which would allow the public to enter into a purchase contract without first seeing the label, should mention the type of hazard indicated on the label. Please note that web pages for products sold on the Internet (i.e. product detail pages) fall within the scope of advertising, so sellers should ensure that product detail pages display all hazard information required by the EU CLP Regulation. Please see the European Chemicals Agency (ECHA) and Q&As agreed with national helpdesks.

For more information on selling chemicals in the United Kingdom (England, Scotland and Wales) and Northern Ireland, refer to Classification, Labelling and Packaging of Chemicals (CLP) in GB or NI.

EU BPR Regulation

Regulation (EU) 528/2012 (EU Biocidal Products Regulation, EU BPR Regulation) involves the placement and use of biocidal products, which protect humans, animals, materials or articles from harmful organisms such as pests or bacteria through the action of the active substances contained in said products. The EU BPR Regulation aims to improve the functioning of the EU market for biocidal products while ensuring a high level of protection for humans and the environment.

Sellers are responsible for complying with the EU BPR regulations and all applicable laws and regulations, and must also comply with the laws and regulations of applicable EU member states.

For more information on the sale of biocidal products in the United Kingdom (England, Scotland and Wales) and Northern Ireland, see Biocides regulation, supply and use.

Definition and Classification

Biocidal products are used to control harmful organisms that are hazardous to human or animal health or the environment, or that cause damage to human activities. These harmful organisms include vermin (e.g. insects, rats or mice) and microorganisms (e.g. bacteria, viruses, molds). Biocidal products include:

Pesticides (except those used for plant protection purposes)
Insect repellents
Disinfectants
Preservatives for materials such as wood, plastics and fabrics
Antifouling paints for the protection of ship hulls

According to the EU BPR Regulations, biocidal products are:

Any substance or mixture consisting of, containing, or producing one or more active substances in the form in which it is offered to the user, that is intended to destroy, retard, render harmless, prevent the action of, or otherwise produce a controlling effect upon any pest by any means other than a mere physical or mechanical action.
Any substance or mixture produced from a substance or mixture which does not itself fall within Category I, that is intended to destroy, retard, render harmless, prevent the action of, or otherwise produce a controlling effect upon any pest by any means other than a mere physical or mechanical action.

Articles treated with a primarily biocidal function shall be considered as biocidal products.

Compliance Check Example(s)

With exceptions, biocidal products must be authorized before they can be placed on the market, and the active substances contained in biocidal products must be approved in advance. This is done in two consecutive steps. First, the active substance is evaluated. If it meets the criteria, it is approved for the specified product type. The second step is to authorize each product that consists of, contains, or results from an approved active substance. The approval of active substances takes place at the EU level, while the subsequent authorization of biocidal products takes place at the Member State level. This authorization can be extended to other Member States through mutual recognition. The EU BPR Regulations also provide applicants with the possibility to obtain a new type of authorization at the EU level (EU authorization). Authorized biocidal products can be found in the Information on Biocides.

Biocidal products should comply with the classification, packaging, labeling, and advertising requirements of the EU BPR Regulations. Any advertisement for biocidal products, including product detail pages for internet sales, should include the information in accordance with Article 72 of the EU BPR Regulations. Such information should be clearly legible and readable.

For more information, see:

EU PPP Regulations

Regulation (EC) No 1107/2009 (EU Plant Protection Products Regulation, EU PPP Regulation) is legislation on the placing of plant protection products (PPP) on the EU market. It sets out the rules for the authorization, sale, use, and control of PPP's within the EU. For more information, see Legislation on Plant Protection Products (PPPs).

Sellers are responsible for complying with the EU PPP Regulations and all applicable laws and regulations, and must also comply with the laws and regulations of applicable EU Member States.

For more information on the sale of plant protection products in the United Kingdom (England, Scotland and Wales) and Northern Ireland, see Pesticides.

Definition and Classification

PPP's are pesticides used to protect crops or desirable or useful plants. They are mainly used in the agricultural sector, but are also used in forestry, horticulture, recreational areas, and home gardens.

According to the EU PPP Regulation, PPP refers to products provided to users in a form that consists of or contains active substances, safeners, or synergists, and is used for one of the following purposes:

Protecting plants or plant products from all harmful organisms or preventing the action of such organisms, unless the primary use of these products is considered to be for hygiene reasons other than the protection of plants or plant products.
Influencing plant life processes, such as substances that affect plant growth, except as nutrients or plant biostimulants.
Preserving plant products, provided that such substances or products are not subject to special provisions on preservatives.
Destroying unwanted plants or plant parts, except algae, unless the product is applied to soil or water for the protection of plants.
Checking or preventing undesirable growth of plants, except algae, unless the product is applied to soil or water for the protection of plants.

Compliance Check Example(s)

PPP's usually contain more than one ingredient. The ingredient that fights pests/plant diseases is called the active substance. The active substance can be a chemical substance or a microorganism. Active substances, safeners, or synergists may only be authorized for use in PPP's if they meet the approval criteria set out in the EU PPP Regulations. Active substances, safeners, or synergists can be searched in the EU database. See Approval of active substances, safeners and synergists.

PPP must be authorized in the relevant EU countries before it can be placed on the market or put into use. The EU PPP Regulations set out the rules and procedures for PPP authorizations. EU countries are responsible for controlling the use and market placement of PPP's. Refer to the Procedure to apply for authorisation of a PPP and the Guidelines on Active Substances and Plant Protection Products for further information.

For information on the illegal and counterfeit pesticide trade, refer to research on the topic.

PPP's should comply with the packaging, labeling, and advertising requirements of the EU PPP Regulations. Unauthorized PPP's are not allowed to advertise. Any advertisement for a PPP, including a product detail page for sale on the internet, should also include the information set out in Article 66 of the EU PPP Regulations, and such information should be clearly legible and readable. PPP should also comply with the classification, labeling, and packaging requirements of the EU CLP Regulations.

EU FPR Regulation

Regulation (EU) 2019/1009 (EU Fertilizer Products Regulation, EU FPR Regulation) sets out the requirements that fertilizer products must meet in order for manufacturers to be able to affix the CE mark to their products and sell them on the single market as EU fertilizer products.

According to the EU FPR, fertilizer products are substances, mixtures, microorganisms, or any other materials used or intended for use on plants or their rhizosphere, mushrooms or their mycosphere, or intended to constitute the rhizosphere or mycosphere, whether used alone or in combination with other materials, with the purpose of providing nutrition to plants or mushrooms or improving their nutritional efficiency. Product categories covered by the EU FPR include: fertilizers, liming materials, soil conditioners, growing media, plant biostimulants, and fertilizer product mixtures. The EU FPR does not cover animal by-products or derived products (which are subject to the requirements of Regulation (EC) No 1069/2009), nor does it cover plant protection products (PPP).

Manufacturers may freely choose to market their fertilizer products as EU fertilizer products (fertilizer products that comply with EU FPR and bear the CE mark) or non-EU fertilizer products (fertilizer products that comply with the national regulations applicable in the EU countries where they sell their products). For more information, see Fertilizer Products and Mutual Recognition Rules.

For more information on selling fertilizer products in Great Britain (England, Scotland, and Wales) and Northern Ireland, see guidance on Manufacturing and Marketing Fertilisers.

EU Detergents Regulation

Regulation (EC) No 648/2004 (EU Detergents and Cleaning Products Regulation) sets out the requirements and obligations relating to detergents, with the aim of enabling the free movement of detergents and detergent surfactants on the internal market while ensuring a high level of protection for the environment and human health.

Sellers are responsible for complying with the EU Detergents and Cleaning Products Regulation and all applicable laws and regulations, and must also comply with the laws and regulations of applicable EU member states.

For more information on the sale of detergents in Great Britain (England, Scotland, and Wales) and Northern Ireland, see Detergents regulation in Great Britain (GB) and Northern Ireland (NI).

Definition and Classification

According to the EU Detergents and Cleaning Products Regulation, a detergent is any substance or mixture containing soap and/or other surfactants used in washing and cleaning processes. Cleansers may be in any form (liquid, powder, paste, stick, block, molded block, shaped, etc.) and may be sold or used for household, institutional, or industrial use.

Other products that can be considered cleaning agents are:

Auxiliary washing preparations for soaking (pre-washing), rinsing, or bleaching laundry, household linen, etc.
Fabric textile softeners, used to change the feel of fabrics during the process and to supplement fabric washing.
Cleaning preparations for household all-purpose cleaners and other cleaning preparations for surfaces such as materials, goods, machinery, mechanical equipment, means of transport and related equipment, apparatuses, appliances, etc.
Other cleaning and washing preparations used for any other washing and cleaning processes.

Compliance Check Example(s)

Provision of information

The manufacturer shall provide the following information to the competent authorities of the Member States:

Information on the results of one or more tests referred to in Annex III to the EU Detergents Regulation.
For surfactants that do not pass the tests referred to in Annex III and for which an exemption is requested under Article 5.

Technical documentation on the results of the tests referred to in Annex II.
Technical documentation on the results and information of the tests referred to in Annex IV.

Documentation of the tests carried out.
The ingredient data sheet as specified in Annex VII C.

The manufacturer shall make the ingredient data sheet. available free of charge to any healthcare practitioner upon request.
Manufacturers of household cleaners must also make a simplified version of the ingredient data sheet available to the public on their website. Access to the website must not be subject to any restrictions or conditions and the content of the Website must be kept up to date. The website should include a link to the Pharmacopoeia Commission website or any other appropriate website that provides a correspondence table for INCI names, names from the European Pharmacopoeia, and CAS numbers.

Surfactant restrictions.

Surfactants that pass the more stringent "ultimate biodegradability test" can continue to be sold on the market.
Industrial or institutional surfactants that do not pass the "ultimate biodegradability test", but do pass the more relaxed "primary biodegradability test" can continue to be sold in the EU and on the Single Market, but only if the manufacturer has obtained an exemption from the European Commission.
Restrictions on phosphates and other phosphorus compounds in household laundry detergents and automatic dishwasher detergents.

Labeling and information

For labeling and information requirements for detergents sold to the public, including fragrance allergens, see Article 11 and Annex VII of the EU Detergents and Cleaning Products Regulations.
Detergents should also comply with the classification, labeling and packaging requirements of the EU CLP Regulations.

For more information, see the Detergents Regulation and Detergents Regulations and Documents.