From 5 January 2021, the European Chemicals Agency (ECHA) will require companies to submit information on any Substance of Very High Concern (SVHC) that are on the REACH1 Candidate List and are used in any articles/complex products that the company places on the European Union (EU) market.
This information will be entered into the Substances of Concern In articles, as such or in complex objects (Products) (SCIP) database. This poses a new challenge for businesses because they must now become familiar with the complex nature of their products in time for the deadline.
Any article containing a SVHC and is being placed on the EU market will need to be declared to the ECHA, including all complex objects where the product is made from more than one article. Companies should be ready to submit information regarding their substance identifiers; name, concentration and location of the SVHC; safe-use information for the articles; and waste management advice according to the ‘Detailed information requirements for the SCIP database’, which was published in September 2019.
The official information requirements set out by ECHA will not change before the 2021 deadline and companies are encouraged to begin preparing their submissions now and keep the following in mind:
- Obligations and information requirements.
- Product portfolio.
- IUCLID software and formatting.
- Integration and utility of your supply chain tracking or safety datasheet (SDS) software.
- Timely collection of relevant information.
This new requirement is a direct result of the amendment to the Waste Framework Directive (2018) (WFD). It comes from ECHA’s overarching aim to move towards a more circular economy by providing waste operators with information to improve their handling of hazardous chemicals at the end of their life cycle. Information submitted will be disseminated to the appropriate parties and the majority of it will be made publicly available, with the main purpose being to provide greater clarity to waste operators.
The amendment to the WFD is in addition to the existing requirements under REACH legislation, wherein any article that contains a Candidate List substance (more than 0.1% of concentration weight by weight) must be communicated to all downstream users in the supply chain and to all consumers. Additionally, ECHA now has to be notified about the article containing the SVHC within 6 months from its inclusion in the Candidate List. Stakeholders now must ensure they keep up to date with their obligations under REACH and the WFD.
While this new legislation comes from the European Commission, it will be the duty of individual Member States to transfer this Directive into their own national law by July 2020. As a result, enforcement of this law may differ depending on the Member State in which your company submits its notifications. ECHA has previously expressed its desire for a largely harmonised format across the EU to avoid a complex process and the duplication of information. We will monitor these discussions closely and continue to update our stakeholders when and if further decisions are made.
We will be hosting a free webinar on ‘SCIP database: what does it mean for your organisation?’ on 9 June, 14:00 (BST).
The webinar will help you understand what the SCIP database is and how to begin preparing for your submissions now. During this webinar, Caroline Raine, who has over 15 years of expertise in the regulatory sector and works closely with various ECHA working groups, will help you understand the new challenges that the SCIP database poses to organisations that now need to become familiar with the requirements prior to the 5 January 2021 deadline.
How can we help?
The SCIP database is proving to be an unpredictable and complex legal requirement. Substances currently on the Candidate List are subject to assessment and review to establish appropriate future action. This action may include inclusion on the Authorisation List and restrictions to use. We maintain an extensive database in conjunction with the ECHA lists – now updated with the SVHCs on the Candidate List – and can offer tailored support and guidance for your product submissions. A check against our database can help you understand the composition of your products better and enable you to be ready to do your notifications in 2021.
Also, our regulatory expert, Caroline Raine, sits on the ECHA working groups and has been active in the guidance provided by ECHA on a variety of legislation. Therefore, she can help you make informed and up-to-date decisions to enable compliance with the ever-changing regulatory landscape. Our in-depth knowledge of the global supply chain means we are ideally placed to assist you in understanding your obligations worldwide and prepare for any future changes.
If you require any further assistance regarding the SCIP database, how to make submissions to this database or any other regulatory legislation, please do not hesitate to contact us.
Relevant links and resources
SVHC Candidate List from ECHA
IUCLID 6 product website
ECHA: Information requirements for the SCIP database
On-demand webinar: What's coming in 2020 in the world of regulatory affairs
Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation
Image copyright: European Chemicals Agency