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2 New SVHCs – What does this mean for REACH compliance?

By Marcus Schneider

The smallest change yet to the SVHC Candidate List has been rolled out – 2 substances have officially been added, bringing the total to 163 substances. Companies now need to assess whether they have legal obligations resulting from the inclusion of substances in the Candidate List. Immediate legal obligations include Communication and Notification. REACH Compliance for your company may include more than this but these are the minimum requirements to be assessed based on the SVHC Candidate List update.


Learn how your REACH program is affected by new SVHCs. Download ‘The REACH Handbook: Your Guide to SVHC Compliance.’


The latest additions are:

  • 1,2-benzenedicarboxylic acid, di-C6-10- alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate
    • EC Number(s): 201-559-5, 271-094-0, 272-013-1
    • CAS Number(s): 68515-51-5, 68648-93-1
  • 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en- 1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5- methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof]

The first new entry covers a series of mixed alkyl diesters which were added to the list due to their reproductive toxicity properties where they contain ≥ 0.3% of dihexyl phthalate (which is already an SVHC and on the authorization list). This group of substances has been noted as being used as plasticisers and lubricants, including use in adhesives, coatings, building material, cable compounding, polymer foils, PVC compounds and artist supply (e.g. modelling clay and finger paints).

The second SVHC has been added as a group entry with very persistent and very bioaccumulative properties. This group of substances covers for example, the product with the trade name “karanal”. Public information sources indicate that the main use of karanal is as a fragrance ingredient.

Any producers or importers of articles placed on the market[1] in the EU must now declare the presence of any of these substances (in addition to the already existing 161 substances) in an article in a concentration exceeding 0.1% w/w.

Furthermore, these same producers and importers have six months from today (15 December 2015)  to notify the ECHA if

(a)   the (SVHC) is present in those articles in quantities totalling over 1 tonne per producer or importer per year

(and)

(b) the (SVHC) is present in those articles above a concentration of 0,1 % weight by weight (w/w),

Any chemicals placed on the Candidate List can also eventually be approved for an authorization list where they will then be banned from use in the EEA (European Economic Area) unless an authorization is submitted and approved before the applicable sunset date.

Where Can I Find More Information About REACH Compliance?

Need help understanding how REACH impacts you? Contact us today.


[1] Article 3.12 of the REACH Regulation specifies:
Placing on the market: means supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market.

Marcus Schneider
Senior Regulatory Expert
Assent

Marcus is a seasoned materials compliance professional with extensive technical experience in data reporting and analysis programs. He is committed to helping companies understand data to not only meet  Read More

Marcus Schneider | Senior Regulatory Expert
Assent

Marcus is a seasoned materials compliance professional with extensive technical experience in data reporting and analysis programs. He is committed to helping companies understand data to not only meet their legal requirements, but also leverage it as a strategic asset to improve business. Before jo...

Read More

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