New EU rules under chemicals and waste legislation require manufacturers and suppliers of products to provide information to a centralized EU database. These rules may also affect the medical devices industry.
Since 5 January 2021, a new obligation to notify the European Chemicals Agency (“ECHA”) applies to suppliers of articles containing substances of very high concern (“SVHCs”) in a concentration above 0,1 % weight by weight (w/w). The obligation is established under the revised Waste Framework Directive 2008/98/EC (“WFD”) which cross-references Regulation (EC) 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (“the REACH Regulation”) and provides the basis for the creation of a new database collating information on “Substances of Concern In articles as such or in complex objects (Products)” (known as “the SCIP database”) to which notifications must be submitted under the supervision of ECHA (Article 9 of WFD).
According to ECHA, the aim of the new notification obligation is to ensure that information on SVHCs is available throughout the whole lifecycle of articles and materials, including the waste stage. SVHCs are hazardous substances (e.g., carcinogenic, mutagenic or toxic for reproduction) included in the Candidate List for authorisation of the REACH Regulation. Information submitted to the SCIP database will be accessible to national authorities, waste treatment facilities, supply chain operators and consumers. ECHA intends to publish the submitted information as received, unless the protection of confidential business information can be justified.
Suppliers subject to notification
Suppliers of an article for the purposes of submissions to the SCIP database are defined in the REACH Regulation as any producer or importer, distributor or other actor in the supply chain (Article 3(33) of REACH Regulation). Therefore, with the exception of retailers, all actors are subject to notification even if a notification has been submitted by an upstream supplier for the same article. ECHA provides, however, some tools allowing for the simplification of the procedure such as the possibility of referring to notifications submitted by the other actors for same articles.
Suppliers of articles containing SVHCs in a concentration above 0,1% w/w are already required by the REACH Regulation to provide, amongst other things, sufficient information regarding these substances to the other actors of the supply chain and to consumers upon request (Article 33 of REACH Regulation). The new obligation to notify ECHA applies in parallel with the obligation to inform other suppliers and consumers.
Suppliers based outside the European Union (“EU”) are not subject to the notification obligation but they will be asked by their EU importers to provide information necessary to fulfil their obligation to notify.
Articles concerned and type of information required
The obligation to notify applies to articles as such or complex objects (incorporating two or more articles). An “article” is defined 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 (Article 3(3) of REACH Regulation).
Guidance on the content of information required for submission is provided in a document issued by ECHA on the Requirements for SCIP notifications. The required information includes a significant amount of data which allows the identification of articles, the name, concentration range and location of the Candidate List substances present in the specific article and other information regarding the safe use of the article.
Medical devices covered by the scope of the obligation
The REACH Regulation does not exclude medical devices from its general scope of application. Only certain medical devices which are invasive or used in direct physical contact with the human body and marketed as mixtures (and not articles) in the finished state, are explicitly exempted from some requirements under the REACH Regulation. However, all medical devices which are articles for REACH purposes are subject to both the existing SVHC notification requirements under REACH and the new SCIP reporting obligations.
ECHA advises that assessment of whether a medical device can be considered an article under the REACH Regulation needs to be done on a case-by-case basis after identifying the function of the object. It is likely, therefore, that many medical devices suppliers will need to consider whether their products are articles containing SVHCs and will have to submit SCIP database notifications, where applicable.
Scope of SCIP database and Brexit
The obligations under REACH and the WFD apply to economic operators established in the EU, but are therefore of course also relevant for those supplying into that market. The United Kingdom (“UK”) has left the EU, with the transition period ending on 31 December 2020. The UK has set up its own chemicals regime which closely mirrors EU REACH, which applied directly in the UK prior to the end of transition. Obligations such as notification to the SCIP database, which enter into force after the end of transition, do not automatically apply for the UK market and it is necessary to consider this separately. It may be that an equivalent database will be set up in the UK, and the national authorities are understood to be considering this, but this is not presently the case.
Enforcement of EU waste and chemicals legislation takes place at Member State level. National regimes and approaches to enforcement can vary, as demonstrated by a multinational review on REACH enforcement and penalties. Typically, enforcement powers include ordering recalls and imposing financial penalties. The introduction of the SCIP database is one of a number of measures in the area of market surveillance being undertaken at EU level to harmonise and make enforcement more effective.
Companies need to ensure that they have appropriate procedures in place to assess whether the articles that they place on the EU market are affected by the new obligation of notification. Additionally, companies subject to the notification will need to maintain good communication relationships with the other actors in the supply chain involved in order to simplify and coordinate data submission.