The obligation covers all articles placed on the EU market containing a substance of very high concern on the Candidate List in a concentration above 0.1% w/w.
Substances fulfilling one or more of the criteria defined in REACH Article 57 can be identified as Substances of Very High Concern (SVHCs) and put on the Candidate List for authorisation. New substances are regularly added to the Candidate List, usually twice a year.
The obligation applies to any article as such or in a complex object, i.e. an object made up of more than one article, because articles that are assembled or joined together remain articles. Furthermore, an import is deemed to be ‘placing on the market’, thus any imported article into the EU is covered by the obligation, including any supply via internet sales that involve an import.
The obligation covers articles, as such or in complex objects, as they are supplied, including “spare parts”. Articles or complex objects that are repaired, provided that they are not supplied, are not covered by the legal duty.
Information on articles supplied directly and exclusively to consumers, without the participation of a distributor or other actor in the supply chain, will not be included in the SCIP database, as any direct supply to consumers is not covered by the legal obligation.
Where necessary, in the interests of defence, Member States may allow for exemptions from the REACH Regulation in specific cases for certain substances on their own, in a mixture or in an article (Article 2(3) of the REACH Regulation).
Therefore, in case a Member State considers that the reporting obligations are detrimental to its national interests in the area of defence, then a Member State may choose to invoke this article to provide a specific exemption from the obligation of Article 33(1) of REACH, and to Article 9(1)(i) of the WFD1 respectfully. Furthermore, Member States are not obliged to supply information the disclosure of which they consider to be contrary to the essential interests of its security (Article 346 TFEU2)
1 Directive (EU) 2018/851 of the European Parliament and of the Council of 30 May 2018 amending Directive 2008/98/EC on waste
2 Treaty on the Functioning of the European Union.
(source: Commission non-paper on the implementation of articles 9(1)(i) and 9(2) of the revised Waste Framework Directive 2008/98/EC, distributed to the CARACAL and Waste Expert Group in June 2019, ref. Ares(2019)3936110).
Substances, mixtures and articles can be contained inside packaging, such as a carton, a plastic wrapping or a tin can. Packaging is to be considered as an article because its shape, surface or design is more important than its chemical composition for its functions. The packaging is not a part of the substance, mixture or article being packaged. It is therefore to be considered as a separate article under REACH and the same requirements apply to it as for any other article.
Furthermore, in complex objects, several articles can be joined or assembled together in various manners. A “complex object” refers to any object made up of more than one article. This does not necessarily exclude the possibility that in certain situations packaging may be one of those articles (e.g. a bottle, the can component in a spray can). Articles that are assembled or joined together remain articles, as long as they keep a special shape, surface or design, which is more decisive for their function than their chemical composition.
Any packaging or packaging components employed to package a substance, mixture or article is an article itself or a complex object and is subject to SCIP notification if that article or any of the articles incorporated in that complex object contains a Candidate List substance in a concentration above 0.1% w/w. For further information see Q&A 516.
A medical device is subject to a SCIP notification obligation if that medical device itself or one of its components:
- fulfils the REACH definition of article, and
- contains a substance of very high concern (SVHC) on the Candidate List in a concentration above 0.1% w/w.
The assessment on whether a medical device itself or one (or more) of its components, can be considered an article under REACH needs to be done on a case-by-case basis after identifying the function of the object. The identification of the function and the assessment should be done by applying the principles contained in the Guidance on requirements for substances in articles, Chapter 2, taking into account the worked examples therein (e.g. Appendices 3 and 4).
The exemption in REACH Article 2(6)(c) is only relevant for the provisions under Title IV of REACH that are applicable to mixtures. Article 33 is included under the same title of REACH, but it is applicable to articles as defined in Article 3(3) of REACH. Therefore, the exemption from Title IV of certain medical devices that are mixtures is not relevant in this context.
As a result, there is no exemption from the duty to communicate information under Article 33 of REACH for suppliers of medical devices fulfilling the REACH definition of article or incorporating a component fulfilling that definition, if it contains a Candidate List substance above 0.1% w/w. A supplier of a medical device fulfilling the REACH definition of article or incorporating a component fulfilling that definition is not exempted of the communication obligations under Article 33(1) and is therefore also not exempted of the SCIP notification obligation under Article 9(1)(i) of the Waste Framework Directive.
- a regulatory change that leads to a mandatory submission of up-to-date information, in particular when a substance present in an article (in a concentration above 0.1% w/w) is included in the Candidate List after 5 January 2021;
- a change in the composition of a complex object, in terms of components and subcomponents incorporating articles as such containing Candidate List substances;
- a request from a Member State authority to submit additional information to a SCIP notification, for example if the submitted information does not ensure compliance with the SCIP notification duty;
- any changes that the submitter considers relevant to update a SCIP notification on a voluntary basis, for example if a Candidate List substance present in an article has been substituted by a safer alternative.