Substance of Very
High Concern (SVHC)
Under REACH, substances that are one of the following can be regarded as substance of very high concern(SVHC):
- carcinogenic, mutagenic or toxic to reproduction (CMRs);
- persistent, bio-accumulative and toxic (PBTs);
- very persistent and bio-accumulative (vPvBs);
- seriously and / or irreversibly damaging the environment or human health, as substances damaging the hormone system;
ECHA has so far released a list of 144 SVHC substances, out of this 22 SVHC Have now been included in Authorization list. This SVHC candidate list is expected to include more substances in the future as Member states suggest more substances for inclusion.
It may be noted that the EU buyers are becoming vary of the SVHC substances and have now started demanding their suppliers to provide proof of No SVHC content in the product and in case it’s there then to demonstrate that various requirements as is required within the REACH regulation is complied.
SSS based upon its assessment process can provide a certificate of “SVHC free” article and in case article contains SVHC then it can facilitate the compliance process as required with REACH and then issue a certificate of REACH compliance article, that can be then issued to various buyers. SSS certified products and chemicals are presently being acknowledged and accepted by over 2000 EU buyers.
The Impact of SVHC
SVHC have posed new challenges to article suppliers. Here articles suppliers mean non-EU article exporters, EU importers and manufacturers of articles.
Under REACH, 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 that does its chemical composition. e.g. automobile, garments, tires, plastics products, electrical products, handicraft, toys, electronics. Thus, the limitation on SVHCs set out in the REACH regulation, has a broad scope, affecting lots of industries.
How can a company achieve SVHC compliance?
Firstly, you need to identify all possible hazardous substances in your products and find out which list they belong to(SVHC candidate list or Restriction list or Authorization list). You may do so by carrying out SVHC testing by yourself or asking your suppliers to carry out testing in the same supply chain.
Then you could adopt the following measures to achieve REACH compliance if a SVHC is present in your products:
Notification: Submit notification to European Chemical Agency (ECHA) if any SVHC on candidate list present in an article has a concentration above 0.1% (w/w) and the total amount of the SVHC exceeds 1 tonne per annum per producer or importer. The SVHC candidate list will be regularly updated from time to time.
Communication Requirement: If any SVHC on candidate list is present in your product with a concentration above 0.1% (w/w), you are obliged to inform the recipients of the article along the supply chain about the chemical name(s) and how the article can be safely used. REACH further requires this information be made available within 45 days upon consumer request.
Restriction: Article suppliers not only need to comply with the requirements of SVHC, they also need to comply with the requirements of REACH Restriction. Some candidate SVHCs (for example, anthracene) are also on REACH restricted substances list (XVII of REACH)They also need to ensure that their products do not contain other REACH restricted substances.
Authorization: Priority SVHCs on candidate list will be included in the Annex XIV of REACH (the "Authorization List"). Those SVHCs will not be allowed to be used, placed on the market or imported into the EU after a date to be set unless the company is granted an authorization.
Our SVHC Compliance Solutions
SSS can carry out an assessment for you or your suppliers, in accordance with your specific industry to choose which items need to be assessed, SSS focuses on eliminating the possibility of a particular SVHC present in a particular article and where the possibility of certain balance SVHC substances cannot be eliminated it recommends the testing of only a limited probable SVHC in the articles, thus improving the efficiency of your testing strategy and saving money on unnecessary testing. Finally, we can supply you with a series of tailor-made ’Assessment Reports‘ to meet you various requirements.
SSS offers REACH restricted substances (RSL) & SVHC screening services in one package for you or your suppliers to help you make sure your products comply with the latest safety requirement of REACH and other legislation. As the SVHC list is constantly updated we also provide a annual maintenance and assessment package where in we would assess your articles for all new SVHC lists that may be updated during a particular 12 months period.
Our services includes
- Applicability assessment of REACH to your export articles
- Determining if there is need to perform testing of any of the SVHC (This shall help in drastically reducing the cost to company for proving conformity with REACH to your buyers.
- Certificate of conformity on the absence of the SVHC
- Notification to the European regulatory authorities if SVHC is present above the established limits
- Technical support in responding to your suppliers and filling the relevant response to their questionnaires
- Certificate of compliance for your European buyers