…Guidance on information requirements for reproductive and developmental toxicity

A draft update to chapter R.7a of ECHA’s guidance on information requirements and chemical safety assessment (IR&CSA) has been sent for consultation to the Competent Authorities for REACH and CLP (CARACAL). The update fully revises the section on reproductive and developmental toxicity.

Relevant changes include the replacement of the requirement for a two-generation reproduction study (when such testing is needed) with an extended one-generation reproductive toxicity study (EOGRTS). Prenatal developmental toxicity (PNDT) testing should also now be conducted in an additional species for high tonnage (≥1000 tonnes/year) substances (Annex X), as opposed to the current stepwise approach, where a second species is not always assessed. Dossiers should be updated accordingly.

ECHA has announced that it will start making decisions on testing proposals on EOGRTS from 1 October, and will address this information requirement in its compliance check decisions. For the change regarding PNDT testing, ECHA has stressed that information requirements may be fulfilled by valid adaptations, and that registrants should avoid unnecessary animal testing.

European Chemicals Agency (2015). Guidance on information requirements and chemical safety assessment. Chapter R.7a: Endpoint specific guidance. Draft Version x.0. May 2015. http://echa.europa.eu/documents/10162/13643/draft_ir_csa_r7a_r76_reprotox_v30_ca_en.pdf How to address the information requirement on pre-natal developmental toxicity. ECHA/NA/15/15. 20 May 2015. http://echa.europa.eu/view-article/-/journal_content/title/how-to-address-the-information-requirement-on-pre-natal-developmental-toxicity

Registrants encouraged to re-assess information on reproductive toxicity. ECHA/NA/15/20. 17 June 2015. http://echa.europa.eu/view-article/-/journal_content/title/registrants-encouraged-to-re-assess-information-on-reproductive-toxicity

…ECHA explains how it evaluates read-across decisions

Under REACH, read-across is the most commonly used approach to fill data gaps on the effects of chemicals on human health and the environment without resorting to laboratory testing on vertebrate animals. Using this concept, the properties of an untested ‘target’ compound are predicted from experimentally-determined data on a ‘source’ compound (e.g. a common transformation product or analogous substance) or source compounds (e.g. categories of substances). Under REACH, ECHA judges whether decisions by dossier registrants to use particular read-across data are justified.

The Agency’s read-across assessment framework (RAAF) provides details of a structured approach for this evaluation process, and a report on the RAAF for the human health hazards of single-constituent substances has recently been published.

European Chemicals Agency (2015). Assessing read-across – how ECHA does it. ECHA/PR/15/07. 26 May 2015. http://echa.europa.eu/view-article/-/journal_content/title/assessing-read-across-how-echa-does-it

Read-across assessment framework (RAAF). ECHA-15-R-07-EN. May 2015. http://echa.europa.eu/documents/10162/13628/raaf_en.pdf



…Recent OECD work highlighted for registrants of dossiers on nanomaterials

In response to the release of new data on eleven nanomaterials by the Organisation for Economic Co-operation and Development, ECHA reminds relevant registrants to consider this information and update their REACH dossiers where necessary.

European Chemicals Agency (2015). OECD releases new data on nanomaterials – registrants asked to consider the information. ECHA/PR/15/08. 9 June 2015. http://echa.europa.eu/view-article/-/journal_content/title/oecd-releases-new-data-on-nanomaterials-registrants-asked-to-consider-the-information



…RAC considers a DNEL and dose-response relationship for two industrial chemicals

A carcinogenicity dose-response relationship for 1,2-dichloroethane and a derived no-effect level (DNEL) for bis(2-methoxyethyl) ether (diglyme) have been agreed by ECHA’s Committee for Risk Assessment (RAC), but have yet to be publically disseminated.

European Chemicals Agency (2015). [No relevant title given.] Annex to news alert ECHA/NA/15/15. 11 June 2015. http://echa.europa.eu/documents/10162/21774240/Annex_RAC_33.pdf


…Committee opinions on restriction proposals

ECHA’s RAC supports a French proposal to restrict the placing on the market of thermal paper (e.g. sales receipts) containing bisphenol A to protect the health of exposed workers. It also supports ECHA’s proposal to restrict the use of decabromodiphenyl ether (decaBDE) as a flame retardant in substances, mixtures and articles due to its persistent, bioaccumulative and toxic (PBT) and very persistent, very bioaccumulative (vPvB) properties, and its potential neurotoxicity.

ECHA’s Committee for Socio-Economic Analysis (SEAC) has meanwhile drafted an opinion on the decaBDE proposal, and has finalised its conclusions on a restriction proposal for inorganic ammonium salts in cellulose insulation materials. SEAC discussions continue on bisphenol A.

European Chemicals Agency (2015). RAC concludes on two restrictions […]. ECHA/NA/15/16. 11 June 2015. http://echa.europa.eu/view-article/-/journal_content/title/rac-concludes-on-two-restrictions-discusses-applications-for-authorisation-and-adopts-harmonised-classification-and-labelling-opinions   SEAC concludes on two restriction proposals […].ECHA/NA/15/19. 16 June 2015. http://echa.europa.eu/view-article/-/journal_content/title/seac-concludes-on-two-restriction-proposals-and-agrees-on-two-draft-opinions-on-applications-for-authorisation



…Two new substances of very high concern (SVHCs) added to the Candidate List

As announced in a recent press release (ECHA/PR/15/09), the total number of entries on ECHA’s Candidate list for authorisation has been brought up to 163 by the addition of group entries for 1,2‑benzenedicarboxylic acid di-C6-10-alkyl esters containing at least 0.3% dihexyl phthalate (listed due to their reproductive toxicity), and mixed (or individual) stereoisomers 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 (e.g. “karanal”) (listed due their vPvB nature).

A decision will be made later as to whether these chemicals will be subject to authorisation. ECHA reminds companies that they may have resulting legal obligations.

European Chemicals Agency (2015).

Two new substances of very high concern (SVHCs) added to the Candidate List. ECHA/PR/15/09. 15 June 2015. http://echa.europa.eu/view-article/-/journal_content/title/two-new-substances-of-very-high-concern-svhcs-added-to-the-candidate-list Background documents available via http://echa.europa.eu/web/guest/candidate-list-table



…Applications for authorisation discussed by RAC and SEAC

ECHA’s RAC and SEAC have considered applications for the authorisation of several uses of trichloroethylene and lead chromate.

European Chemicals Agency (2015). RAC […] discusses applications for authorisation […].ECHA/NA/15/16. 11 June 2015. http://echa.europa.eu/view-article/-/journal_content/title/rac-concludes-on-two-restrictions-discusses-applications-for-authorisation-and-adopts-harmonised-classification-and-labelling-opinions SEAC […] agrees on two draft opinions on applications for authorisation. ECHA/NA/15/19. 16 June 2015. http://echa.europa.eu/view-article/-/journal_content/title/seac-concludes-on-two-restriction-proposals-and-agrees-on-two-draft-opinions-on-applications-for-authorisation



…Other items of interest

Testing proposals involving vertebrate animals: request for information from third parties on five substances (deadline 6 or 27 July). http://echa.europa.eu/information-on-chemicals/testing-proposals/current


New summary table available for applications for authorisation. http://echa.europa.eu/view-article/-/journal_content/title/new-summary-table-available-for-applications-for-authorisation


REACH Regulation ((EC) No. 1907/2006) amended by Commission Regulation (EU) 2015/830 regarding Annex II (requirements for the compilation of safety data sheets). http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:JOL_2015_132_R_0004&from=EN


The above items were taken from the July 2015 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here)

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