10 July 2015
REACH Dangerous Chemicals List Grows: Obligations May Ensue for Hong Kong Suppliers that Use Them
On 15 June 2015, the European Chemicals Agency (ECHA) added new substances of very high concern (SVHCs) to the REACH Regulation’s Candidate List. These new substances are not single substances, but rather chemical groups or mixtures. They are as follows:
- The first is a mixture of 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) and has been included in the Candidate List because it was ruled as toxic for reproduction.
- The second is a group of substances containing 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  [covering any of the individual stereoisomers of  and  or any combination thereof], and has been included in the Candidate List because it was ruled as very persistent and very bioaccumulative (vPvB).
The first of the above-mentioned groupings may be used as a plasticiser or lubricant, e.g., in adhesives, coatings, building material, cable compounding, polymer foils, PVC compounds and artists’ supplies. The second grouping is largely used as a fragrance ingredient (‘karanal’). Karanal is used in applications for the manufacture of (among others) soaps and detergents.
Hong Kong traders already familiar with the REACH Candidate List will know that the inclusion of any substance onto the Candidate List creates legal obligations for companies manufacturing, importing or using such substances, whether on their own, in mixtures or in articles.
In the case of articles: From the date of inclusion onto the Candidate List (thus, in the present case, from 15 June 2015), suppliers of articles which contain the substances in a concentration above 0.1% (w/w) have to provide sufficient information to allow safe use of the article to their customers (“recipients”); or, upon request, to a consumer within 45 days of the receipt of the request. This information must contain as a minimum the name of the substance.
Producers or importers of articles within the EU, have to notify ECHA if their article contains a substance on the Candidate List. This obligation applies if the substance is present in those articles in quantities totalling over one tonne per producer or importer per year and if the substance is present in those articles above a concentration of 0.1% (w/w). The notifications have to be submitted no later than six months after the inclusion. A notification is not required when the producer or importer of an article can exclude exposure of humans and the environment during the use and disposal of the article. In such cases, the producer or importer shall however supply appropriate instructions to the recipient of the article. A notification is also not required when the substance has already been registered for that use.
In the case of substances (on their own): From the date of inclusion (i.e. from 15 June 2015), suppliers of substances on the Candidate List have to provide their customers in the EU with a safety data sheet.
In the case of substances in mixtures: From the date of inclusion (i.e. from 15 June 2015), suppliers of mixtures not classified as dangerous according to Directive 1999/45/EC have to provide the recipients, at their request, with a safety data sheet if the mixture contains at least one substance on the Candidate List and the individual concentration of this substance in the mixture is ≥ 0.1% (w/w) for non-gaseous mixtures if the substance is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB).
This is without prejudice to the general obligation for all suppliers of mixtures not classified as dangerous (according to EU law) to provide the recipients, at their request, with a safety data sheet if the mixture contains a substance with an individual concentration ≥ 1% (w/w) for non-gaseous mixtures and ≥ 0.2% by volume for gaseous mixtures where that substance poses human health or environmental hazards.
The Candidate List currently contains 163 substances, of which 31 have subsequently been included in the so-called “Authorisation list” (Annex XIV of REACH). SVHCs that are included in the Authorisation List become subject to authorisation. This means that the substances cannot be placed on the EU market or used in the EU after a given date, unless an authorisation is granted for their specific use, or the use is exempted from authorisation.
Please click on the following to examine the updated Candidate List.