A substance of very high concern (SVHC) is a chemical substance with concerns that have been regarding their use within the European Union(EU). These substances are subject to authorization under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulations, which were set on December 18, 2006.
REACH addresses the production and use of chemical substances, and their potential impacts on both human health and the environment. Regulations that are vital as many dangerous substances could cause harm to humans or the environment and therefore need to be managed and controlled.
What Does SVHC Mean?
SVHC substances are officially classified as of very high concern:
- Substances that are carcinogenic, mutagenic or toxic for reproduction (CMR category 1 or 2)
- Persistent, bioaccumulative and toxic substances (PBTs)
- Very persistent and very bioaccumulative substances (vPvB)
- Substances that are potential endocrine disruptors
You need to be aware of these substances and what the criteria is for classifying a substance as a SVHC as there are over 1000 substances that could potentially fulfil the relevant criteria categories. SVHC specifically refers to substances that fall within the above hazard categories and are placed by the Commission of the European Union on the Candidate List of substances considered for authorization.
What is the SVHC list?
Since 2008, the list has grown steadily, at an average rate of 35 substances per year and the list is updated regularly and on June 25th, 2020, the European Chemicals Agency (ECHA) added four new SVHCs to the Candidate List. Therefore, bringing the total number of entries to 209.
The four new SVHCs are:
- 1-vinylimidazole
- 2-methylimidazole
- Dibutylbis(pentane-2,4-dionato-O,O’)tin – an organotin compound that has similar properties and/or uses to SVHC candidate dibutyltin dichloride
- Butyl 4-hydroxybenzoate (Butylparaben)
The ECHA SVHC Roadmap states an EU-wide commitment to ensuring all relevant and known SVHCs will be on the candidate list by the end of 2020. Any supplier of a substance containing an SVHC that is on the list with a concentration above 0.1% has a duty to provide the recipient of the substance sufficient information to allow safe use of the article within 45 days.
What Is a SVHC Declaration?
REACH requires that all manufacturers and importers must register all substances that are manufactured or imported in quantities of one tonne or more per year. Including individual substances, mixtures or substances in articles that are intended to be used under normal circumstances. If you make chemicals, either to use yourself or to supply to other people, then you will probably need to ensure your substances are REACH compliant.
The Difference Between REACH and SVHC
If a substance is on the REACH category list, it doesn’t necessarily mean it will feature on the SHVC list. The list of SVHCs and the Restricted Substances List are two processes and a substance may be on either without necessarily being listed on the other. Under EU REACH, substance data must be collected from suppliers and provided to customers when a Substance of Very High Concern (SVHC) is present over the allowed threshold.
REACH applies to substances, mixtures and articles, impacts most products placed on EU market. The exemption products of REACH are defined by the Act of each Member States, such as defence, medical, veterinary medicines and foodstuffs. As stated above, there are potentially more than 1,000 substances that may fall within the scope of these regulations. The EU currently lists 209 and plans to complete the list with all known substances this year which could add many hundreds more substances to the list.
Any product that contains more than 0.1% of any of these substances is determined to be within scope. The major issue for suppliers is how to determine whether any of the Candidate List SVHCs are present in their products and at what level. This task is made more difficult by the continuous expansion of the Candidate List. SVHCs have been shown to be contained in a range of consumer products, including shoes, clothing, toys, electronics etc., but manufacturers and retailers are not always aware of their presence.
About AQM BD
AQM BD is a third-party inspection company and can consult regarding chemical substances, take part in SVHC screening tests, process audits and can help to enter your company in a series of REACH awareness training programs. AQM BD test chemicals, electrical and electronic products, motors, shoes, leather and accessories.
Combine this with AQM BD’ quality standards and services and you have a powerful, profitable and productive commercial proposition. AQM BD will help ensure your company is both SVHC and REACH compliant.
Sources:
https://www.ecomundo.eu/en/substances-traceability-svhc/substance-very-high-concern-definition
https://www.yordasgroup.com/svhcs#:~:text=SVHC%20stands%20for%20’Substance%20of,or%20toxic%20for%20reproduction%20(CMR)
https://www.sgs.com/en/news/2020/06/safeguards-09720-eu-svhc-candidate-list-updated-to-contain-209-entries
https://www.chemsafetypro.com/Topics/EU/REACH_Regulation_EC_No_1907_2006.html
https://blog.assentcompliance.com/index.php/ask-the-experts-reach-restricted-substances-candidate-lists/
