REACH SVHC List 2017 Includes New Requirements for Manufacturers

REACH SVHC List 2017 Updates

The following changes to the REACH SVHC List were published by the European Chemical Agency on 2 March 2017, giving manufacturers 18 months to apply for authorization.

• Seven chemicals added to the list of substances of very high concern (SVHC) with deadlines set for compliance
• Manufacturers are now limited to importing no more than 1 tonne of SVHCs per year and their products must not contain SVHCs in concentrations above 0.1% (weight by weight)
• New directives were also issued to ensure manufacturers stay up to date with amendments to the REACH SVHC list and inform their supply chain.

REACH SVHC Categories

CMR: Carcinogenic, mutagenic or reprotoxic

PBT: Persistent, Bio-accumulative and Toxic

vPvB: Very Persistent and Very Bio-accumulative

What Does REACH Stand for?

REACH (Registration, Evaluation, Authorisation, and restriction of Chemicals) is an acronym for the procedure and guidelines that manufacturers must follow to have their products certified by the European Chemical Agency (ECHA).

The REACH procedure became law on 1 June 2007. It applies to manufacturers of the following types of products:

• Electrical & Electronics: TVs, heaters, computers, mobile devices, etc.
• Hardlines: furniture, cosmetics, printing & packaging, hardware, sports equipment, etc.
• Softlines: clothing, footwear, garments and apparel, soft toys, fabric, and textiles
• Toys and Childcare Products

REACH Procedure for Manufacturers Using SVHCs

The letters ‘REA’ in REACH stands for Registration, Evaluation, Authorization. Manufacturers must follow these steps to obtain certification for products containing SVHCs before they qualify to be placed on the market in the EU.

Registration

Manufacturers and importers of products containing SVHCs have to be registered with the European Chemical Agency (ECHA) in order to supply or place products on the EU market.

Manufacturers and importers located outside the EU (non-EU companies) have to rely on an EU REACH Only Representative to submit registration on their behalf.

Evaluation

Registration dossiers submitted are examined by the ECHA in terms of completeness and data requirements. ECHA will also assess a substance of concern for its environment/public health impact.

Authorization

Listed Substances of Very High Concern (SVHC) in Annex XIV will not be allowed to be used, placed on the market or imported into the EU after data to be set, unless the company is granted authorization.

Changes to the REACH SVHC List

The REACH SVHC list is usually updated on an annual basis. Manufacturers are obligated to be aware of any changes to the REACH SVHC list and must apply to the ECHA for authorization before the application deadline (sunset date), usually 18 months after publication of the changes, after which products containing the restricted substances are prohibited from being placed on the market.

New Changes in the REACH Exemption List 2018

Two significant changes to the REACH Exemption List were made in 2018, which manufacturers should be aware of to ensure they meet the latest requirements under REACH article 7(2) and REACH article 33.

REACH article 7(2)

Seven new substances and/or combinations of substances were added to the REACH SVHC list in 2018.

2018 SVHC List Additions:

1. vPvB substances used in fragrances, soaps, and detergents:

• 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane
• 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane

2. CMR substances used in coatings, cleaning agents, binders and release agents, polymer processing and water treatment:

• 1-Methyl-2-pyrrolidone (NMP)
• 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyland hexyl and octyldiesters with ≥ 0.3% of dihexyl phthalate (EC No. 201-559-5)

3. PBT & vPvB substances used in manufacture of plastics products, formulation and use of adhesives and sealants, printing inks and UV stabilizers:

• 2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328)

4. vPvP & PBT substances used at industrial sites and in plastic products and coatings:

• 2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol(UV-327)
• 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol(UV-350)
• 2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320)

REACH Article 33 – Obligation to Communicate

Manufacturers of products containing SVHCs in a concentration above 0.1% (weight by weight) are obligated to provide safety data sheets or chemical safety reports to professional users and distributors in their supply chain. The reports must be provided within 45 days, free of charge.

How can QIMA help you?

As an authorized REACH Only Representative (OR), QIMA provides a comprehensive range of laboratory testing, consultation, and data delivery services for REACH SVHC compliance.

We have over 2,000 inspectors, auditors and lab experts to ensure your product and suppliers meet all safety and performance standards with the required safety data sheets and chemical safety reports for your industry.

Our services give you access to hundreds of off-the-shelf customizable inspection checklists online, expert advice on your product safety requirements and supplier auditing programs to ensure compliance at the source.

Use the contact form to make an inquiry.