REACH compliance for products you sell: the limits, the 0.1% rule and SCIP

REACH is the EU chemicals law. A shirt, a phone case, a bracelet or a toy is an “article” in its words: an object whose shape, surface or design decides its function more than its chemical composition does (Art. 3(3)Regulation (EC) No 1907/2006, REACH (chemicals)Article 3, point 3Click opens the article on EUR-Lex.).

An article that carries a biocide, such as a textile treated against bacteria or a mattress treated against dust mites, has its own rules under the Biocidal Products Regulation.

Which limits hit consumer goods: Annex XVII

A substance “in an article, for which Annex XVII contains a restriction shall not be manufactured, placed on the market or used unless it complies with the conditions of that restriction” (Art. 67(1)Regulation (EC) No 1907/2006, REACH (chemicals)Article 67, paragraph 1Click opens the article on EUR-Lex.). The limit sits on the product, whoever sells it. Placing on the market means supplying it to anyone else, paid or free, and import counts as placing on the market (Art. 3(12)Regulation (EC) No 1907/2006, REACH (chemicals)Article 3, point 12Click opens the article on EUR-Lex.).

These entries name consumer goods directly. REACH Annex XVII holds more, and the entry that binds you is whichever one names your product or its material. A separate regulation, the POPs Regulation, bans persistent organic pollutants in any article above a trace limit, outside REACH.

The phthalate limit on all articles has its own exemptions, among them articles only for industrial or agricultural use or only for outdoor use where no plasticised material touches mucous membranes or stays on the skin, food-contact materials, medical devices, and electrical and electronic equipment within the scope of Directive 2011/65/EUDirective 2011/65/EU, Restriction of Hazardous Substances (RoHS)The whole regulationClick opens the law on the EU Publications Office. (Annex XVII entry 51(4)). The lead limit for small articles excludes, among others, keys and locks, musical instruments, brass with up to 0.5% lead, and toys under Directive 2009/48/ECDirective 2009/48/EC, Toy Safety DirectiveThe whole regulationClick opens the law on the EU Publications Office. (entry 63(8)). The PAH limits do not apply to articles first placed on the market before 27 December 2015 (entry 50(7)).

For nickel the law names the test method: “The standards adopted by the European Committee for Standardisation (CEN) shall be used as the test methods” (entry 27(3)). For azo dyes the methods are those listed in Appendix 10 (entry 43(1)).

When substances of very high concern trigger the 0.1% duty to inform

ECHA keeps the Candidate List of substances of very high concern and updates it on its website each time a substance is added (Art. 59(10)Regulation (EC) No 1907/2006, REACH (chemicals)Article 59, paragraph 10Click opens the article on EUR-Lex.). ECHA states that the duties run “from the date of inclusion”, so a product that was clean last year can carry a duty today without any change to the product.

The duty falls on every “supplier of an article”: the producer, the importer, the distributor “or other actor in the supply chain placing an article on the market” (Art. 3(33)Regulation (EC) No 1907/2006, REACH (chemicals)Article 3, point 33Click opens the article on EUR-Lex.). A reseller is a supplier. The business you supply is a “recipient”; a consumer is not one, which is why consumers get the information on request only (Art. 3(35)Regulation (EC) No 1907/2006, REACH (chemicals)Article 3, point 35Click opens the article on EUR-Lex.).

The 0.1% is counted per component, not per product. The Court of Justice ruled in 2015 that the supplier of a product one or more of whose constituent articles contains a substance of very high concern above 0.1% “of that article” must inform the recipient and, on request, the consumer (Case C-106/14, judgment of 10 September 2015). A shoe is a sole, an upper, laces and eyelets. A bag is fabric, a zip, a strap and a buckle. Each one is weighed on its own.

Candidate List substances are those that meet the criteria of Art. 57Regulation (EC) No 1907/2006, REACH (chemicals)Article 57Click opens the article on EUR-Lex. and are identified under Art. 59(1)Regulation (EC) No 1907/2006, REACH (chemicals)Article 59, paragraph 1Click opens the article on EUR-Lex.: substances that meet the criteria of the CLP Regulation for carcinogens, mutagens or reproductive toxicants of category 1A or 1B, PBT and vPvB substances, and substances of equivalent concern such as endocrine disruptors. ECHA notes that the list’s data is moving to its chemicals database, ECHA CHEM, and that the table stays up to date on its current page until December 2026.

A separate notification to ECHA, which rarely reaches a reseller. A producer or importer of articles notifies ECHA when a Candidate List substance is present in its articles above 0.1% and “in quantities totalling over one tonne per producer or importer per year” (Art. 7(2)Regulation (EC) No 1907/2006, REACH (chemicals)Article 7, paragraph 2Click opens the article on EUR-Lex.), within six months of the substance’s inclusion (Art. 7(7)Regulation (EC) No 1907/2006, REACH (chemicals)Article 7, paragraph 7Click opens the article on EUR-Lex.). No notification is due where exposure to people and the environment can be excluded, in which case instructions go to the recipient instead (Art. 7(3)Regulation (EC) No 1907/2006, REACH (chemicals)Article 7, paragraph 3Click opens the article on EUR-Lex.), or where the substance is already registered for that use (Art. 7(6)Regulation (EC) No 1907/2006, REACH (chemicals)Article 7, paragraph 6Click opens the article on EUR-Lex.). The tonne counts the substance, not the goods.

Where the same information goes: SCIP, the ECHA database

The Waste Framework Directive makes each EU country ensure that any supplier of an article, in the REACH sense, sends the Art. 33(1)Regulation (EC) No 1907/2006, REACH (chemicals)Article 33, paragraph 1Click opens the article on EUR-Lex. information to ECHA “as from 5 January 2021” (Art. 9(1)(i)Directive 2008/98/EC, Waste Framework DirectiveArticle 9, paragraph 1, point (i)Click opens the article on EUR-Lex. of Directive 2008/98/EC). ECHA runs the database, SCIP, and opens it to waste operators and, on request, to consumers (Art. 9(2)Directive 2008/98/EC, Waste Framework DirectiveArticle 9, paragraph 2Click opens the article on EUR-Lex. of Directive 2008/98/EC).

Because SCIP carries the information owed to business recipients, it follows that duty. ECHA says who is covered: EU producers and assemblers, EU importers, EU distributors and other actors placing articles on the market; and “Retailers and other supply chain actors supplying articles directly and exclusively to consumers are not covered by the obligation to provide information to the SCIP database.” That exclusion does not reach a retailer that is also an importer or a producer (ECHA, Requirements for SCIP notifications, sections 1.2 and 1.3). Buy from outside the EU and sell only to consumers, and you are the importer: SCIP is yours. Buy inside the EU and sell only to consumers, and it is not. Sell to one business, a shop or a reseller, and it is. The SCIP database guide sets out who files and what goes in.

Each notification identifies the article, names the Candidate List substance with its concentration range and where in the article it sits, and gives what is needed for safe use and waste handling, per ECHA. Because the duty comes from a directive, each EU country sets it in its own law, with its own penalties.

Who is the importer

REACH puts its import duties on an “importer”: “any natural or legal person established within the Community who is responsible for import”, where import is “the physical introduction into the customs territory” (Art. 3(10)Regulation (EC) No 1907/2006, REACH (chemicals)Article 3, point 10Click opens the article on EUR-Lex., Art. 3(11)Regulation (EC) No 1907/2006, REACH (chemicals)Article 3, point 11Click opens the article on EUR-Lex.). ECHA’s reading for companies outside the EU: “REACH and CLP only apply to legal entities established in the European Union” and the other EEA countries, and the duties lie “with the importers established in the European Union, or for REACH obligations, with the only representative”.

The only representative route belongs to “a natural or legal person established outside the Community who manufactures a substance… formulates a mixture or produces an article that is imported” (Art. 8(1)Regulation (EC) No 1907/2006, REACH (chemicals)Article 8, paragraph 1Click opens the article on EUR-Lex.). ECHA’s page on the role says: “You are not an only representative if: Your non-EEA supplier is a distributor”.

REACH is on the list of Union harmonisation legislation in Annex I to Regulation (EU) 2019/1020Regulation (EU) 2019/1020, Market Surveillance RegulationThe whole regulationClick opens the law on the EU Publications Office. (point 22), so that Regulation’s market surveillance and border rules apply to articles under REACH (Art. 2(1)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 2, paragraph 1Click opens the article on EUR-Lex. and Art. 25(3)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 25, paragraph 3Click opens the article on EUR-Lex. of Regulation (EU) 2019/1020Regulation (EU) 2019/1020, Market Surveillance RegulationThe whole regulationClick opens the law on the EU Publications Office.). REACH is not among the laws in Art. 4(5)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 5Click opens the article on EUR-Lex. of Regulation (EU) 2019/1020Regulation (EU) 2019/1020, Market Surveillance RegulationThe whole regulationClick opens the law on the EU Publications Office., so that Regulation’s own rule requiring an EU-based operator for a product does not come from REACH. If you sell to consumers, GPSR has its own rule on an EU-based contact, set out in the EU Responsible Person.

What to get from your supplier

REACH hands out no certificate, no registration number for a finished product and no declaration of conformity, and it puts no CE marking on anything. What shows compliance is evidence that the product meets the limits that apply to it. That evidence comes from whoever knows the materials, which is your supplier.

What happens if you do nothing

A product over an Annex XVII limit may not be placed on the market at all (Art. 67(1)Regulation (EC) No 1907/2006, REACH (chemicals)Article 67, paragraph 1Click opens the article on EUR-Lex.). Authorities can require you to bring it into compliance, stop it being made available, withdraw or recall it, or destroy it (Art. 16(3)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 16, paragraph 3Click opens the article on EUR-Lex. of Regulation (EU) 2019/1020). At the border, customs suspend release of a product where there is cause to believe it does not comply (Art. 26(1)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 26, paragraph 1Click opens the article on EUR-Lex. of Regulation (EU) 2019/1020). Fines are set by each EU country, which REACH requires to be “effective, proportionate and dissuasive” (Art. 126Regulation (EC) No 1907/2006, REACH (chemicals)Article 126Click opens the article on EUR-Lex.).

What you can skip

What the law leaves open

• Who the importer is when a parcel goes from outside the EU straight to an EU consumer. Art. 3(11)Regulation (EC) No 1907/2006, REACH (chemicals)Article 3, point 11Click opens the article on EUR-Lex. requires the importer to be in the EU and “responsible for import”. A business outside the EU is not in the EU, and a consumer buying for personal use is not supplying anyone. No article of REACH names who carries the importer duties on that route, and ECHA’s reading is that REACH applies only to businesses in the EU and the EEA. The Annex XVII limit does not depend on the answer, because Art. 67(1)Regulation (EC) No 1907/2006, REACH (chemicals)Article 67, paragraph 1Click opens the article on EUR-Lex. binds the article itself. Meanwhile, meet the limits, keep the test reports, and answer consumer requests as a supplier would.
• Whether a seller outside the EU is itself a “supplier of an article”. Art. 3(33)Regulation (EC) No 1907/2006, REACH (chemicals)Article 3, point 33Click opens the article on EUR-Lex. lists “other actor in the supply chain placing an article on the market” and, unlike the importer and distributor definitions, sets no condition on where that actor is. ECHA’s page for non-EU companies says REACH applies only to EU entities. The text does not settle it.
• How to test phthalates, PAHs and lead in an article. Annex XVII names the test method for nickel (entry 27(3)) and for azo dyes (entry 43(1)), but entries 50(5), 51(3) and 63(1) set limits without naming a method. Meanwhile, a report that names its method lets anyone repeat the test.