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Liz Jan 03, 2016 04:33 PM
Dear everyone
                     First of all - Happy New Year
I would be grateful if you could let me know if the following statement on your website is still true (updated 2008) or has there been an update
"For 75% of the 2,000 - 3,000 large volume chemicals on the market there is insufficient toxicity and eco-toxicity data publicly available for "minimal" risk assessment under OECD guidelines."
I will be giving a presentation on Tuesday!
Thank you
Kind regards
Replies (1)
EEA Jan 04, 2016 05:17 PM
Hello Liz,

We can no longer claim that this statement from our 2008 report is valid.

The availability of information on chemicals on the market has been significantly improved by implementation of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

To summarise: Under REACH, manufacturers and importers of substances are required to submit a registration to the ECHA for each substance manufactured or imported in quantities of 1 tonne or above per year, with the registration dossiers to the hazard information and, where relevant, an assessment of the risks that the use of the substance may pose and how these risks should be controlled. The registration dossier represents the key tool through which crucial data on the hazards associated with substances, and where relevant exposure assessment and risk assessment, are generated by industry and then channelled from industry to regulators.

The specific information requirements of the registration dossier are tiered according to the tonnage volumes of a substance placed on the market. The higher the tonnage, the more information on the intrinsic properties of the substance is required. A chemical safety report (CSR) is required for substances manufactured or imported in quantities starting at 10 tonnes and must be submitted as part of the registration dossier.

Registration requirements for phase-in/existing substances are staggered by tonnage to make the process manageable for both industry and regulators.

A 2012 RPA report also finds that information generated under REACH is resulting in changes in classification, with the majority of these being more restrictive classifications, in particular endpoints such as acute toxicity, sensitisation, reproductive toxicity and aquatic toxicity (acute and chronic). They found that the percentages classified after registration increased across all of the endpoints being considered, and suggest that the reliability of classifications is improving with increased information on substances properties. Since classifications then drive the need for a CSA (at 10 + tonnes) including exposure scenarios and recommended risk management measures in their extended Safety Data Sheets (eSDS), this will increase available information on safe chemicals management.

That is not to say there are not weaknesses in the quality of the registration dossiers. ECHA has found the dossiers to be of a low average quality and this calls into question the quality of the available information.

Reference: RPA, 2012, Assessment of health and environmental benefits of REACH, ENV.D.3/SER/2011/0027r, available at:[…]/health_env_benefits_en.htm

Kind regards.