Doruksistem – Services
REACH Compliance
REACH compliance for companies exporting articles to the EU: intended release, Candidate List SVHCs and Annex XVII restrictions.
Our REACH Compliance Services
Article 3(3) of the REACH Regulation defines an article as “an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition.”
Many everyday products are articles: furniture, clothing, vehicles, tools, books, toys and electronic devices. An article can be as simple as a wooden chair or as complex as a computer. The first step in REACH compliance is to determine whether your product is an article. ECHA’s REACH guidance documents (including the guidance on requirements for substances in articles) can help, or you can consult our experts.
3 Key Questions for Article Suppliers
Article suppliers must answer three key questions to determine their REACH compliance obligations:
1) Is there an intended release of a substance from the article?
If there is an intended release and the quantity of the substance intended to be released exceeds 1 tonne per year per producer or importer, the substance must be registered with the European Chemicals Agency (ECHA) (REACH Article 7(1)). If a mixture is added to the article, this calculation is made for each substance in the mixture. In that case, consult our experts about your registration and CLP obligations.
If there is no intended release, continue with the questions below.
2) Does the article contain an SVHC from the Candidate List?
Some chemicals are carcinogenic, mutagenic or toxic for reproduction (CMR), persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB). Substances of equivalent concern, such as endocrine disruptors, are also covered. These are known as substances of very high concern (SVHCs). One of the aims of REACH is to control them through the authorisation procedure and to encourage their substitution with safer alternatives.
ECHA publishes SVHCs in the Candidate List and updates it twice a year (usually in January and June). Substances on the Candidate List may later be included in REACH Annex XIV (Authorisation List).
Companies supplying articles to the EU market should ask their suppliers whether their products, including packaging, contain Candidate List substances. Please contact us for sample letters in English and Turkish for this communication. Suppliers of articles containing a Candidate List substance above 0.1% by weight:
- must provide recipients with sufficient information for safe use (at least the name of the substance) and provide this information to consumers on request within 45 days (REACH Article 33);
- must notify ECHA within 6 months of the substance’s inclusion in the Candidate List if the substance is present in their articles above 1 tonne per year per producer or importer (Article 7(2));
- have had to submit information on these articles to ECHA’s SCIP database since 5 January 2021 (Waste Framework Directive, Article 9(1)(i)).
According to the judgment of the Court of Justice of the EU of 10 September 2015 (C-106/14), the principle of “once an article, always an article” applies: in complex objects, the 0.1% threshold is calculated for each article that makes up the product, not for the product as a whole. Consult our experts for examples of SVHC calculations.
Even if you do not currently use a Candidate List substance, remember that the list is updated regularly and must be monitored. To stay one step ahead, it is worth following ECHA’s Registry of Intentions and lists published by some NGOs; substances on these lists are likely to be added to the Candidate List in the future. You can benefit from our REACH compliance consultancy services.
3) Are substances in the article restricted under Annex XVII?
For the management of EU-wide risks that cannot be adequately controlled otherwise, a procedure has been introduced in which the manufacture, placing on the market or use of certain dangerous substances will be subject to certain conditions or prohibited. Restrictions are published as a list based not only on the substance name, but also on the usage area (condition). The restriction should be followed by article suppliers working for the EU market, as the restriction may also apply to the use of a substance in an article.
The REACH Regulation also inherits the restrictions previously applied in the EU. Check your products against the current Annex XVII list of restricted substances; Annex XVII checks are an integral part of REACH compliance. New restrictions are added regularly, for example on synthetic polymer microparticles (microplastics) and PFHxA.