EU Adds Five Substances to the SVHC Candidate List

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January 4, 2016

SAFEGUARDS | Consumer Products NO. 003/16

On December 17, 2015, the European Chemical Agency (ECHA) has added five Substances of Very High Concern (SVHCs) to the Candidate List. [1] Two substances are UV filters, PFNA is an analog of PFOA and the remaining two substances are chemical intermediates. The addition of five new SVHCs brings the total number from 163 to 168 entries.

Obligations for article producers and importers

According to Article 33 of REACH, manufacturers and importers of articles in the European Union (EU) and European Economic Area (EEA) are required to provide information to allow the safe use of the products to their recipients upon supply and to consumers within 45 days upon request, when the concentration of any SVHC in the article exceeds 0.1% (w/w). Under Article 7 of REACH, the manufacturers or the importers of articles that contain SVHCs at concentrations above 0.1%, and at a quantity of more than one tonne per year, shall submit a notification to ECHA. Notification of SVHCs in an article shall be made within six months of their inclusion on the List. The notification deadline for the five new SVHCs added to the Candidate List is June 17, 2016.

SVHC CANDIDATES

Two UV filters – 2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327) and 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350) are included due to their very persistent and very bioaccumulative properties. [2], [3] They are used as UV-protection agents in coatings, plastics, rubber and polyurethanes.

Perfluorononan-1-oic acid (PFNA) is an analog of perfluorooctanoic acid (PFOA). PFNA is similar to PFOA in physicochemical, toxicological and ecotoxicological properties. [4]

The remaining two substances nitrobenzene and 1, 3-propanesultone are chemical intermediates. [5], [6]

Dicyclohexyl phthalate was included in a previous consultation list (September 1, 2015). However, it was withdrawn from this list and transferred to the intention list on November 18, 2015. It is expected that the dossier will be submitted on February 1, 2016.

Hexamethylene diacrylate is another substance included in a previous consultation list, due to its skin sensitizing properties. A minority of members commented that skin sensitization seemed to be reversible in nature (at the elicitation stage) and not as severe as the carcinogenic, mutagenic or reprotoxic (CMR) effects. The European Commission will prepare a draft proposal on the identification of this substance as an SVHC and take a final decision during the committee procedure.

Table 1: Possible uses of 5 SVHC in the Candidate List published by ECHA on 17 December 2015

No.	Substance	CAS No./ EC No.	Classification	Potential uses
1	2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327)	3864-99-1 / 223-383-8	vPvB	Used as UV-protection agents in coatings, especially for cars and special industrial wood coatings Used as UV-protection agents for plastics, rubber and polyurethanes Used in cosmetics as sun protection agents
2	2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350)	36437-37-3 / 253-037-1	vPvB
3	1,3-propanesultone	1120-71-4 / 214-317-9	Carc. 1B	Used as an intermediate in the manufacture of fine and bulk chemicals Used as a pre-product to manufacture aqueous polyurethane dispersions Used as pre-product for the manufacture of light-sensitive dyes for photographic and radiographic films Use in the electrolyte fluid in the production of lithium ion batteries
4	Nitrobenzene	98-95-3 / 202-716-0	Repr. 1B	Used as an intermediate under strictly controlled conditions (SCC) Use as processing aid and use as solvent for the preparation of formulations
5	Perfluorononan-1-oic acid (2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,9-heptadecafluorononanoic acid and its sodium and ammonium salts)	375-95-1; 21049-39-8; 4149-60-4 / 206-801-3	Repr. 1B / PBT	Used as a processing aid for the fluoropolymer manufacture, most notably for polyvinylidene fluoride Used as lubricating oil additive, surfactant for fire extinguishers, cleaning agent, textile antifouling finishing agent, polishing surfactant, waterproofing agents and in liquid crystal display panels

ABBREVIATIONS

Carc. 1B: Carcinogen category 1B
vPvB: Very persistent and very bioaccumulative
Repr. 1B: Toxic for reproduction category 1B
PBT: Persistent, bioaccumulative and toxic

SVHCs may be introduced into consumer products as a result of the complexities of both the supply chain and production process. Identifying high risk products, or materials, or having a test strategy, can be a smart way to ensure compliance and save costs. If you would like to learn more about how SGS can support your REACH compliance activities please visit www.sgs.com/reach.

For enquiries, please contact:

Corey So
Corporate Research and Development
t: + 852 2774 7150 ext.1150

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