Committee for Risk Assessment (RAC) adopts 13 scientific opinions on the harmonised C&L of various industrial chemicals

Amongst these substances are:

·        Pitch, coal tar, high temperature (CTPHT)

·        N-ethyl-2-pyrrolidone (NEP):

·        1-Octadecanamine (Octadecylamine)

·        (Z)-octadec-9-enylamine

·        Hydrogenated tallow alkyl amine (Amines, hydrogenated tallow alkyl)

·        Coco alkyl amine (Amines, coco alkyl)

·        Tallow alkyl amine (Amines, tallow alkyl)

·        Aluminium Phosphide

·        Trimagnesium diphosphide

·        Ammoniumpentadecafluorooctanoate (APFO)

·        Perfluorooctanoic acid (PFOA)

·        1,3-cyclohexanedione, 2-[2-chloro-4-(methylsulfonyl)benzoyl] (Sulcotrione)

·        Gallium Arsenide

RAC are responsible for

·         Preparing the opinion of ECHA on applications for authorisation, proposals for restrictions and proposals for harmonised classification and labelling

·         Preparing opinions on specific questions relating to risks of chemicals to human health or the environment

More information can be found at

http://echa.europa.eu/news/na/201112/na_11_54_rac_18_19_en.asp

Alternative Chemical Name Requests - ECHA launches a new procedure
A new online form allows manufacturers, importers and downstream users to request the use of alternative chemical names. Companies may choose to do this if they believe that the disclosure of a substance name on the label of their mixtures or in the safety data sheets reveals business secrets or intellectual property.
Suppliers of mixtures (e.g. paints) must inform users of any hazardous ingredient in the mixture by disclosing its chemical identity (name, CAS number and trade name if applicable). Under certain conditions, ECHA or EU Member States authorities may grant exemptions from this obligation. Article 24 of CLP allows the submission of requests for the use of an alternative name for the substance not to be revealed. Before such exemptions are granted, ECHA examines whether the safe use of the mixture may be compromised.
Manufacturers, Importers and Downstream Users will submit their application for using an alternative name to ECHA if the overall mixture is classified and labelled according to the CLP Regulation (comes into force in 2015).
If the mixture is still classified and labelled according to the Dangerous Preparations Directive (DPD), the alternative name request has to be submitted to a Competent Authority in one of the EU Member States where the substance is placed on the market.
On the ECHA website, navigate in the panel on the left hand side CLP >> Alternative Chemical Name in Mixtures for more info.

REACH law applied to nanomaterials

It has been argued that the characteristics of nanoparticles (e.g. increased toxicity and or persistency) demand specific regulation between nano-scale substances and their bulk equivalent at the micro or macro scale. In REACH there is no mention of nanoparticles/nanoscale materials anywhere in its 800+ pages of text. However, in December 2006, shortly after the regulation’s adoption by the European Parliament, the European Commission posted on its website a question-and-answer document that includes the following:
 
How will nanoparticles be treated under REACH?

“Substances in the nano-scale fall under the scope of REACH, and their health and environment properties must therefore be assessed following the provisions of this Regulation.  However, methodologies for identifying hazards and evaluating risks of substances at the nano-scale need to be further refined over the next few years.”

“The European Commission is funding research projects to assess the health and environment impacts of nano particles under the 7th Research Framework Programme.”

ECHA updates the REACH Candidate List

On Monday June 20th, 2011, seven new substances were added to the Candidate List http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp of substances of very high concern for authorisation, taking the total to 53.

Companies may have immediate legal obligations http://echa.europa.eu/chem_data/authorisation_process/candidate_list_obligations_en.asp following such inclusions that are linked to the listed substance on its own, in mixtures and within articles. Of particular note, EU and EEA suppliers of articles that contain more than 0.1% by weight of a Candidate List substance must provide sufficient information to their customers to allow safe use of the article (Article 33 Duty to Communicate). The same information must be given to consumers on request within 45 days of receiving the request.

Additionally, EU and EEA importers and producers of articles containing more than 0.1% by weight of a Candidate List substance may be required to notify ECHA within 6 months of the substance being added to the Candidate List where the substance quantity exceeds 1 tonne per year. More information on notification of substances in articles is available on ECHA's website at http://echa.europa.eu/reach/sia_en.asp. Recordings and the presentations from ECHA's notification webinar on 19 May are freely available at http://echa.europa.eu/news/webinars_en.asp

In addition to the seven new Candidate List substances, the existing entry for cobalt (II) chloride has been updated due to its classification as toxic for reproduction. Cobalt (II) chloride was originally identified as an SVHC in October 2008 because of its classification as carcinogenic.

For more information please see the ECHA Press Release http://echa.europa.eu/news/pr/201106/pr_11_15_svhc_candidate_list_en.asp .

Lessons will be learnt from REACH survey

A study will be conducted to assess the impact of REACH on the operation of the single market and the competitiveness of the European chemicals industry, carried out by the European Commission.

The idea is to get a feel for how competitive the European market is post REACH, and also to get an idea of the costs of it’s administration.

The survey is addressed to:
•manufacturers and importers of chemical substances
•downstream users, distributors of chemicals and
•other firms involved in the different stages of the chemicals supply chain that may be affected by the REACH Regulation.

The link to the survey webpage is: http://cses.co.uk/reach_survey . The survey has been translated to 22 European languages. Respondents have until the 15th July 2011 to reply to the survey.

If you need more information on the purposes of the study please do not hesitate to get in contact a member of the H2 Compliance team.

In our last quarterly newsletter, we spoke about the CLP Regulation. This will require EU companies to update the Classification, Labelling and Packaging of their substances and mixtures over the next 5 years.

The key obligations under the CLP Regulation are as follows:

Key Dates

• From December 1st, 2010 substances must be classified in accordance with the CLP regulation.
• From June 1st, 2015 mixtures must be classified in accordance with the CLP regulation.
• A notification of the classification and labelling of substances must be made to ECHA for hazardous substances and substances subject to registration under REACH by December 1st, 2010.