Certificate of SVHC compliance

Certification to place an article into the EU market. Let us take care of the compliance of your product!

SVHC compliance - EU REACH and Waste Framework Directive

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

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)”

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Substances of very high concern (SVHC)

According to REACH (EC) No 1907/2006, substances of major concern are chemicals that:

meet the criteria to be classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) category 1A or 1B following the CLP Regulation (EC) No 1272/2008.
are persistent, bioaccumulative, and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to Annex XIII of EU REACH regulation.
on a case-by-case basis, cause an equivalent level of concern as CMR or PBT/vPvB substances.

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”

We are experts in EU REACH matters and can act as your REACH Only Representative in Europe. Let us help you manage the complex requirements of EU REACH compliance.

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EU REACH compliance assessment

EU Regulations on SVHCs in articles

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.

EU REACH on SVHCs in articles (Regulation (EC) No 1907/2006)

Obligation to inform customers and consumers

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.

Obligation to notify ECHA

Under REACH Regulation (EC) No 1907/2006, if there is an SVHC present in an article:

in a concentration above 0.1% w/w, and
in quantities totaling over one tonne per manufacturer or importer per year

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.

Waste Framework Directive (2008/98/EC) on SVHCs in articles

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.

How do SVHC compliance obligations concern your products?

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.

The process to obtain the certificate of SVHC compliance for the EU & EEA market

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.

Our SVHC compliance assessment process includes:

Gathering the necessary information about all chemicals contained in the article from the product development and procurement departments and any other parties in the supply chain, if available, such as:

Safety data sheets, bill of materials (BOM), manufacturing process, SVHC testing reports, product databases, annual quantity, use & exposure scenarios, etc.

Checking if the article contains substances with restrictions on the use which is listed in the Annex XVII of REACH.

Assessing if the article contains any component that is intended to be released, dissolved, or evaporated from the product during use.

Analyzing if the article contains SVHCs in the updated Candidate List.

Determining if the article meets the SVHC exemption criteria.

Identifying all SVHC compliance obligations placing on the article of interest.

If an SVHC substance is present in an article in a concentration of more than 0.1% w/w

the supplier of such an article is required to submit a SCIP notification to ECHA.
the supplier must provide information on SVHCs and the safe use of the product to their customers in the supply chain.
the supplier must provide information on SVHCs and the safe use of the product to consumers within 45 days from the receipt of the request.

If an article contains an SVHC in a concentration of more than 0.1% w/w and the total amount of that substance in the product exceeds one ton per year per producer or importer

a separate REACH notification of importing or manufacturing of the article must be submitted to ECHA no later than 06 months from the inclusion in the Candidate List.

FAQs

Is testing compulsory for SVHC compliance assessment?

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.

We are not 100% sure if the concentration of an SVHC contained in our product is over 0.1% w/w. Does Chementors assist with test planning?

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.

Is it possible to submit only one notification to ECHA and that notification will be automatically transferred to both REACH and SCIP databases?

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.