SAFEGUARDS | Consumer Products NO. 096/15

On 15 June 2015, European Chemical Agency (ECHA) has included 2 Substances of Very High Concern (SVHCs) to the Candidate List. One substance is used as additive in plastic. The other substance is a fragrance. The addition of two new SVHC brings the total number from 161 to 163 entries.


According to Article 33 of REACH, European Union (EU) and European Economic Area (EEA) manufacturers and importers of articles that contain a concentration of SVHC in excess of 0.1% (w/w) are required to provide information to allow safe use of the products to the recipients upon supply and to the consumers within 45 days upon request. For articles that contain SVHC at a concentration above 0.1% with the total quantity of the substance over one tonne per year, a notification shall be submitted to ECHA by the manufacturers or the importers under Article 7 of REACH. The notification shall be made within 6 months after their inclusion of new substances to the List. The notification deadline for the 2 new SVHCs added to the Candidate List is 15 December 2015.


Two SVHCs were placed on the Candidate List for Authorisation on 15 June 2015. [1]

The first substance, 1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters (CAS No. 68515-51-5; EC No. 271-094-0); 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters (CAS No. 68648-93-1; EC No. 272-013-1), with ≥0.3% of dihexyl phthalate (CAS No. 84-75-3; EC No. 201-559-5), meets the criteria of article 57 (c) of Regulation (EC) 1907/2006 (REACH) owing to their classification as Repr. 1B [2]. It is noteworthy that dihexyl phthalate has been included in SVHC candidate list since December 16 2013.

The second substance is registered as trade name Karanal (EC No. 413-720-9), which is a commonly used fragrance ingredient. The substance is a reaction mass of 5-sec-butyl-2-(2, 4-dimethylcyclohex-3-en-1-yl)-5-methyl-1, 3-dioxane, and 5-sec-butyl-2-(4, 6-dimethylcyclohex-3-en-1-yl)-5-methyl-1, 3-dioxane. The listing covers any of the individual isomers of these substances or any combination thereof. These substances are nominated as SVHC based on vPvB properties.[3] The listing covers a total of 12 CAS numbers.

Table 1

Possible uses of 2 SVHC in the Candidate List published by ECHA on 15 June 2015



CAS No./

EC No.


Potential uses<


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 No. 201-559-5)




Repr. 1B

  • - Used in polymer preparations and compounds and in plastic articles for building materials.
  • - Additive in lubricants and adhesives.
  • - Additive in coatings, paints, thinners, paint removes fillers, putties, plasters, modeling clay, finger paints, ink and toners, rubber and plastic articles for artist supply.


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 isomers of [1] and [2] or any combination thereof



  • Fragrance ingredient

Repr. 1B: Toxic for reproduction category 1B
vPvB: Very persistent and very bioaccumulative

SVHC may be introduced into various consumer products due to the complexities of both the supply chain and production process. Laboratory testing provides reliable evidence to determine if chemical substances exist in products and information on their volume and concentration. Identifying high risk products or materials or having a test strategy can also 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

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