- Regulation (EU) 2023/988 — General Product Safety Regulation, Article 16
- Regulation (EC) No 1272/2008 — CLP
- Regulation (EC) No 1907/2006 — REACH
Who has to appoint one
Any manufacturer, importer or online seller established outside the Union that places non-medicated pet care products on the EU market. Under Article 16 GPSR a product may not be placed on the market at all unless an economic operator established in the Union is responsible for it: the manufacturer if EU-based, otherwise the importer, otherwise an authorised representative with a written mandate, otherwise a fulfilment service provider. A UK company selling into Ireland is in scope in exactly the same way as a US or Chinese one, because the United Kingdom is a third country for this purpose since Brexit.
Thresholds and exemptions
None. A single distance sale to a consumer in one member state is enough, and there is no exemption for small businesses, handmade products or samples. The obligation attaches to making the product available on the market, which includes offering it for sale online even before the first order is shipped.
What must appear on the label
The manufacturer's name, registered trade name or trade mark, and postal address. The name, registered trade name or trade mark and postal address of the responsible person established in the Union, including an electronic address. A product identifier — type, batch or serial number — that allows the specific production run to be identified. Warnings and safety information where the product presents a risk, in the language of the member state. Where the mixture is classified under CLP, the pictograms, signal word, hazard and precautionary statements and the UFI code linked to the poison centre notification. Under Article 19 GPSR the manufacturer and responsible person details, the product identifier and the warnings must also be visible in the online listing before the consumer buys, not only on the bottle.
Marketplace fields
Amazon, eBay, Etsy, Zalando, Kaufland and TikTok Shop all block or suppress listings where the EU responsible person field is empty or holds a third-country address. Several also require that the label image show the responsible person block legibly. Where the product is CLP-classified, the pictograms must appear in the listing images too. Reinstatement is usually quick once the details are entered, but the responsible person must be a real entity that has accepted the mandate in writing: marketplaces increasingly verify the certificate.
Documentation you must hold
Technical documentation proportionate to the risk, kept for ten years and produced to an authority on request. A product safety assessment covering foreseeable use and foreseeable misuse, including use on species other than the one intended and accidental ingestion by animals or children. The full formulation with INCI or chemical names and CAS numbers. Supplier safety data sheets for every raw material. Microbiological and stability data supporting the shelf life and the preservative system. Where the mixture is classified, the CLP classification file, the safety data sheet and the poison centre notification with the UFI. Records of complaints, incidents and any corrective actions, which the responsible person must be able to see.
Standards and testing
There is no single mandatory harmonised standard for pet grooming products, so the testing programme is derived from the risk assessment. In practice: microbiological challenge testing to validate the preservative, stability testing at accelerated and real-time conditions to support the shelf life, pH measurement, heavy metal screening where mineral pigments or clays are used, and where the label carries skin-tolerance or hypoallergenic claims, evidence capable of substantiating them. Claims without evidence are treated as misleading commercial practice, which is a separate infringement from product safety.
Language requirements
Warnings, safety information and instructions for use must be in the official language or languages of each member state where the product is sold. Ireland and Malta accept English; every other market needs its own. If the mixture is CLP-classified the hazard and precautionary statements must be in the national language too, on the label itself and not only in an online description.
When it applies
Everything must be in place before the first unit reaches an EU consumer. The responsible person's details must be on the product or its packaging from the first shipment, and in the online listing from the moment the offer goes live. Poison centre notification, where required, must precede the first sale in each member state.
How long records are kept
Technical documentation and the safety assessment for ten years from the date the product was placed on the market. Traceability records identifying suppliers and business customers for the same period. Complaint and incident records for as long as the product is on the market plus the statutory period, because the responsible person has to be able to demonstrate that complaints were assessed.
What happens if you do not comply
Marketplace suppression first, which is commercially the most immediate. Then a formal request for documentation from a national authority, usually with a short deadline. Then a withdrawal order, a recall at your expense, or a ban on making the product available. A Safety Gate alert follows for products presenting a risk, is public and names the brand. National fines vary widely: several member states set them as a percentage of turnover, others as fixed maxima in the tens of thousands of euros. Customs can also refuse the consignment at the border.
Who enforces it
National market surveillance authorities for consumer products, poison centres for CLP-classified mixtures, customs at the point of entry, and consumer protection authorities for claims. Marketplaces act as a first filter under the GPSR and the Digital Services Act.
Where the boundary lies
The claim, not the formula, decides the regime, and this is where most sellers get caught. 'Cleans and conditions the coat' is a cosmetic-style claim on a general consumer product: GPSR applies. 'Kills fleas', 'repels ticks', 'antibacterial' or 'disinfects' is a biocidal claim and moves the product to Regulation 528/2012, which requires an authorised active substance and a product authorisation in each member state — a process measured in years, not weeks, and one a responsible person cannot substitute for. 'Treats dermatitis' or any therapeutic claim makes it a veterinary medicinal product under Regulation 2019/6. In the other direction, the Cosmetics Regulation never applies here: it covers products for the human body only, so a 'cosmetic-grade' pet shampoo is still a GPSR product.
Questions we are asked
- We only sell into Ireland — is this really needed?
- Yes. Ireland is an EU member state and applies GPSR in full. Volume is irrelevant: the obligation attaches to the first unit made available.
- Is one responsible person enough for all 27 member states?
- Yes. A single responsible person established anywhere in the Union covers the whole internal market. What changes country by country is the language of the warnings and safety information, and the poison centre notification where the mixture is classified.
- Our formula is identical to a human shampoo — does that change anything?
- No. What matters is the product's intended use. A shampoo presented for animals is not a cosmetic under Regulation 1223/2009, however the formula reads.
- Can we put the responsible person only on the website?
- No. The details must be on the product or its packaging, and separately in the online listing before purchase. One does not replace the other.
Who signs for you
EU representative Europe Services, SE — Na Čečeličce 425/4, Smíchov, 150 00 Praha 5, Czech Republic
UK representative REP27 LTD — Unit 82a James Carter Road, Mildenhall, Suffolk IP28 7DE, United Kingdom