6th Jun 2012

June REACH update

…ECHA assessment of di-isononyl (DINP) and di-isodecyl phthalate (DIDP)

An ECHA draft review report found current legislation preventing the use of DINP and DIDP in toys and childcare articles which can be placed in the mouth to be justified, and sufficiently protective of childhood exposure. A potential risk for liver toxicity was identified for adults using sex toys containing DINP and, in particular, DIDP, but it was noted that there were substantial uncertainties regarding exposure duration and migration rates. Comments on this report are welcomed by 31 July 2012.

European Chemicals Agency. Evaluation of new scientific evidence concerning DINP and DIDP in relation to entry 52 of Annex XVII to Regulation (EC) No 1907/2006 (REACH). Draft review report. Version 3. 7 May 2012.

http://echa.europa.eu/documents/10162/dbc0e16f-eb29-4382-98a1-c08a33149fdc

 

…More proposals for harmonised classification and labelling

Under EC Regulation No. 1272/2008 on Classification, Labelling and Packaging, there is a legal obligation for suppliers to evaluate the hazards of chemicals (substances and mixtures) to be placed on the market, and to classify and label them appropriately. An option also exists for Member State Competent Authorities or industry to ask for the classification and labelling of a substance to be harmonised across Europe, whereupon the European Chemicals Agency organises a public consultation period of 45 days. Under this scheme, proposals have been recently submitted by the Austrian, Dutch, French, German and UK authorities to standardise the classification and labelling of:

http://echa.europa.eu/harmonised-classification-and-labelling-consultation

 

…RIVM reports on prioritisation in REACH and CLP

A RIVM report describes “a priority setting system used for applying policy priorities related to the various work processes under REACH and CLP Regulations”, with the hope to aid policy efficiency. The system operates in three stages: the prioritisation of substances according to hazardous properties and exposures; further process-specific prioritisation (where necessary); and prioritisation according to available time and capacity. Managing substances that are carcinogenic, mutagenic or toxic to reproduction (CMR), persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) was determined to be of highest priority. RIVM recommended creating, and further developing, databases and (quantitative) structure activity relationship models for the detection of such substances, as well as updating its system to account for other substances causing specific effects or concerns (e.g. toxicity to the nervous or immune systems).

Schuur AG and Traas TP (2011). Prioritisation in processes of the European chemical substances regulations REACH and CLP. RIVM report 601352001/2011. Dutch National Institute for Public Health and the Environment (RIVM). Ministry of Health, Welfare and Sport.

http://www.rivm.nl/bibliotheek/rapporten/601352001.pdf

 

…RIVM methodology for use in socio-economic analysis (SEA)

Under REACH, SEA involves the comparison of potential socio-economic costs of particular proposals (such as those for the authorisation and restriction of chemicals), with potential impacts on human health and/or the environment. A recently proposed tiered approach from RIVM determines and compares expected environmental effects of chemical compounds to provide information on hazardous substances and potential alternatives for use in SEA. To investigate the value of its methodology, RIVM hopes to expand the scope to other impact categories such as human health and socio-economic cost, and recommends the development of valuation methods.

Verhoeven JK et al. (2012). From risk assessment to environmental impact assessment of chemical substances. Methodology development to be used in socio-economic analysis for REACH. RIVM report 601353002/2012. Dutch National Institute for Public Health and the Environment (RIVM). Ministry of Health, Welfare and Sport.

http://www.rivm.nl/bibliotheek/rapporten/601353002.pdf

 

…Other items of interest

ECHA’s Committee for Risk Assessment has considered a proposal from Germany to harmonise the classification and labelling of nitrobenzene.

http://echa.europa.eu/web/guest/opinions-of-the-committee-for-risk-assessment-on-proposals-for-harmonised-classification-and-labelling

ECHA publishes updated Guidance on the Application of the CLP Criteria.

http://echa.europa.eu/web/guest/view-article/-/journal_content/2f414bdc-abf6-4f9c-9023-f286c3685e25

ECHA publishes updated Guidance for monomers and polymers.

http://echa.europa.eu/web/guest/view-article/-/journal_content/4ae905b2-32a9-4172-92d3-a0419544bf11

ECHA publishes updated Guidance on registration.

http://echa.europa.eu/documents/10162/13632/registration_en.pdf

ECHA publishes three new appendices to update Chapters R.7a, R.7b and R.7c of the IR & CSA Guidance with regard to nanomaterials. (Scroll down to bottom of webpage.)

http://echa.europa.eu/web/guest/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment

ECHA published revised Fact Sheet on Guidance on data sharing.

http://echa.europa.eu/documents/10162/13631/data_sharing_en.pdf

Chesar support temporarily suspended until new version is released.

http://echa.europa.eu/view-article/-/journal_content/44c53c5b-a8af-4866-8e51-d26c12551c1d

Testing proposals involving vertebrate animals: request for information from third parties on six substances (deadline 14 June 2012; 2 July 2012).

http://echa.europa.eu/information-on-chemicals/testing-proposals/current

The above items were taken from the June 2012 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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