In February 2020, the European Chemicals Agency (ECHA) released the first prototype of the ‘Substances of Concern In articles, as such or in complex objects (Products)’ (SCIP) database.
The SCIP prototype enables relevant duty holders to familiarise themselves with the format and submission tools developed by ECHA, before the official database is launched later this year. Companies can practise preparing a SCIP dossier and the process involved in the notification to the database. All data submitted to the prototype will be deleted as ‘test’ data before the official process begins. Users are also encouraged to provide feedback as improvements and updates will continue to be made before the deadline.
As from 5 January 2021, the ECHA will require companies to submit information for inclusion in the database on any substance of very high concern (SVHC) that will be used in articles/complex products that an organisation places on the European Union (EU) market.
Any article containing an SVHC that is on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation Candidate List (more than 0.1% of concentration weight by weight) will need to be notified to the ECHA within 6 months from inclusion of the SVHC onto the List.
Companies should be ready to submit information regarding their substance identifiers; name, concentration and location of the SVHC on the article; 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. 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 supply chain tracking or safety datasheet (SDS) software.
- Timely collection of relevant information.
This new requirement comes from the revised Waste Framework Directive (WFD) of the European Commission. Although the WFD is an EU directive, it will be the duty of each Member State to transpose the amendment into national law by 5 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 expressed its desire to work with Member States to achieve a largely harmonised format to avoid a complex process and duplication of information. NCEC 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 we can 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 onto the ECHA ‘Authorisation List’ followed by use restrictions. 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 better understand the composition of your products and enable you to be ready to submit your notifications in 2021.
Our regulatory team can help you make informed 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.
- SCIP Prototype
- SVHC Candidate list from ECHA
- Authorisation list from ECHA
- ECHA: Information requirements for the SCIP database
- Blog: ECHA launches SCIP database for substances of very high concern
Image Copyright European Chemicals Agency