Certification to place an article into the EU market. Let us take care of the compliance of your product!
For an article to be legally sold in EU territory, its chemicals must be clarified, and necessary measures should be taken to comply with local laws.
The certificate of SVHC compliance prepared by Chementors certifies that your products comply with the EU regulations on substances of very high concern (SVHC).
Furniture, clothes, shoes, toys, jewelry, laptops, containers, bicycles etc., any of these products is considered “an article” in EU REACH legislation. This means that EU REACH regulation would matter to your business.
“Article means 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 (EU REACH (EC) No 1907/2006)”
According to REACH (EC) No 1907/2006, substances of major concern are chemicals that:
Substances of major concern can cause adverse effects throughout their life cycle on the people involved in the supply chain and on the environment. Therefore, the EU has set specific chemical regulations to protect all parties involved in the supply chain of such chemicals.
Once classified as an SVHC, the substance shall be included in the Candidate List published by the European Chemicals Agency (ECHA). The inclusion in the Candidate List will enact immediate legal obligations on suppliers of the substance which presents either on its own, in a mixture, or articles.
The Candidate List is regularly reviewed and updated every 6 months with new hazardous chemicals added to the List. Therefore, it is important to check if a substance of interest has become an SVHC under EU regulation.
“The EU Candidate List of SVHC is updated frequently. Parties involved in the supply chain should thoroughly assess to confirm if their products contain any SVHC at the concentration values and quantities that shall put in force the corresponding legal obligations”
EU REACH compliance assessment
As an effort to achieve the EU’s safe and sustainable chemical ambitions, EU importers and manufacturers have legal obligations under the REACH Regulation (EC) No 1907/2006 and the Waste Framework Directive (2008/98/EC) on SVHCs contained in articles.
These obligations come into force immediately from the date of inclusion of substances in the Candidate List.
Failure to comply with these regulations may lead to penalties by the regulatory authorities and cause a significant negative impact on the credibility of the business. Therefore, to maintain corporate responsibility, protect business competitiveness, and prevent financial losses, every producer, assembler, importer, and distributor of articles/products should ensure compliance with these legal obligations at all times.
When supplying articles containing substances in the Candidate List in a concentration above 0.1% w/w, suppliers of such articles bear the responsibility to provide sufficient information to allow the safe use of the article to the customers.
When there is a request from a consumer, suppliers of such articles must provide sufficient information to allow the safe use of the article within 45 days from the receipt of the request.
Under REACH Regulation (EC) No 1907/2006, if there is an SVHC present in an article:
the producers or importers of that article shall bear the legal obligation to submit a notification to ECHA within 06 months from the date of the inclusion of the substance in the List.
Depending on the exposure scenarios of an article during its use and disposal, SVHC notification obligation could be exempted. It is the duty of the producer or the importer of the article to conduct the life cycle assessment to ensure that the exemption conditions are met.
Under the Waste Framework Directive (2008/98/EC), when supplying an article containing an SVHC in a concentration above 0.1% w/w in the EU, the suppliers of that article must submit a SCIP notification to ECHA. This information on articles containing the Candidate List substance is then published in the SCIP database by the Waste Framework Directive to make it available to waste operators and consumers.
Due to the above requirements, it is critical for suppliers of such products to check and ensure their full compliance with the corresponding EU regulations on SVHCs. Failing to comply with these legal provisions shall put enterprises into disadvantageous situations of the stop of sales/importing/manufacturing, withdrawal of products, and/or other penalties.
Due to the importance and complexity of SVHC compliance duties, a competent professional should handle the compliance assessment.
At Chementors, we are conscious of this fundamental. Our team consists of experts who have in-depth knowledge of chemistry and REACH & SCIP regulations, and experience in SVHC compliance assessment. We are competent to assist you.
We provide a full service from SVHC compliance assessment to compliance certification. The outcome of the process is the assessment result and based on that the certificate of SVHC compliance, upon request, is issued. This certificate is a communicative means which could be passed down to the supply chain for reference to certify that the article fulfills the requirements set in the EU regulations regarding SVHCs.
No, it is not. Under the EU regulations on SVHC, it is the responsibility of enterprises to identify and prove that their products are fully compliant with the terms and conditions set in the regulations. In the end, enterprises should be able to provide sufficient justifications.
Justifications can be in the forms of test results, facts and figures from scientific research, and expert judgment based on all available data related to the products, literature, read-across approach, etc.
Testing is a reliable and strong method to qualitatively and quantitatively identify SVHC in the article. During the assessment, the competent authorities may request enterprises to provide test results if other justifications are not sufficient to confirm compliance.
Hence, if test data is not available and the project’s schedule is favorable, it would be good to assess all other data from the enterprises and from the published literature which are relevant to the product. Based on that, the testing step can be considered.
Yes, we do. After assessing available data, we will build up a test plan which is customized to substance properties and the project’s needs.
Upon request, we can contact and discuss with the lab about testing requirements and test results to ensure the compliance and compatibility of the data with the corresponding regulations.
No, it is not. Despite a few similarities, REACH notification and SCIP notification are different in terms of application scope, information requirements, deadline, and IT system. Therefore, they should be submitted separately.