…Updated test requirements for local toxicity, acute dermal toxicity and sensitisation

The information requirements for irritation/corrosion to the skin and eye, and for acute dermal toxicity, have been updated in the regulatory text (and entered into force on 20 June), such that non-animal testing is now the default. Amendments for skin sensitisation testing are expected in Autumn 2016.

ECHA (2016). REACH annexes amended – registrants to use alternative test methods. ECHA/NA/16/20. http://echa.europa.eu/view-article/-/journal_content/title/reach-annexes-amended-registrants-to-use-alternative-test-methods

European Commission (2016). Commission Regulation (EU) 2016/863 of 31 May 2016 amending Annexes VII and VIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards skin corrosion/irritation, serious eye damage/eye irritation and acute toxicity. Official Journal of the European Union. L 144/27-31. 1 June 2016. http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R0863&qid=1465220101993&from=en

…European Commission requests ECHA evaluations of rubber, bisphenol S and cadmium

ECHA has been asked by the EC to carry out a preliminary evaluation of the health risks that might be posed by certain substances present in recycled rubber granules, which are used as infill on artificial turf sports grounds. The results of the evaluation are expected in early 2017.

The EC also asked ECHA to carry out a survey of bisphenol S in thermal paper, and to review exemptions to existing restrictions on cadmium and cadmium compounds (e.g. in paints).

European Chemicals Agency (2016). ECHA evaluating whether recycled rubber filling on artificial sports grounds poses a health risk. ECHA/NI/16/26. http://echa.europa.eu/view-article/-/journal_content/title/echa-evaluating-whether-recycled-rubber-filling-on-artificial-sports-grounds-poses-a-health-risk



…RAC and SEAC opinions on authorisation

ECHA’s Committee for Risk Assessment (RAC) has agreed on draft opinions on the authorisation of uses of hexavalent chromium (Cr VI) compounds (mainly in chrome plating and corrosion inhibition), arsenic acid (in the electronics industry), and 1,2-dichloroethane (EDC) and diglyme (bis(2-methoxyethyl) ether) (as solvents).

The Committee on Socio-Economic Analysis (SEAC) also discussed Cr VI compounds, EDC and diglyme, as well as an application for the use of technical MDA (oligomeric reaction products of formaldehyde with aniline).

European Chemicals Agency (2016).

RAC agrees on 33 draft opinions for authorisation and adopts 8 opinions on harmonised classification and labelling. ECHA/NA/16/22. http://echa.europa.eu/view-article/-/journal_content/title/rac-agrees-on-33-draft-opinions-for-authorisation-and-adopts-8-opinions-on-harmonised-classification-and-labelling

[No relevant title.] ECHA/NA/16/23. http://echa.europa.eu/view-article/-/journal_content/title/committee-for-socio-economic-analysis-concludes-on-restricting-d4-and-d5



…SEAC conclusion on the restriction of two siloxanes

A proposal to restrict the use of octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5) in “wash-off” personal care products, such as shower gels, shaving foams and shampoos, was the subject of further discussion by ECHA’s SEAC.

European Chemicals Agency (2016). Committee for Socio-economic Analysis concludes on restricting D4 and D5. ECHA/NA/16/23. http://echa.europa.eu/view-article/-/journal_content/title/committee-for-socio-economic-analysis-concludes-on-restricting-d4-and-d5



…Proposals on restriction

An Annex XV report submitted by the Danish authorities proposes restrictions on the placing on the market of sprays containing (3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silanetriol and its mono-, di- or tri-O-(alkyl) derivatives, “TDFAs”, at ≥2 ppb. The sprays concerned are those using organic solvents and intended for supply to the general public. The key concern is lung toxicity, as seen in short-term rodent studies.

Meanwhile, ECHA (in collaboration with the Danish Environmental Protection Agency) has proposed that articles containing plasticised materials with ≥0.1% (by weight) of bis(2-ethylhexyl) phthalate (DEHP), benzyl butyl phthalate (BBP), dibutyl phthalate (DBP) or diisobutyl phthalate (DIBP) (alone or in combination) should not be placed on the market. Some exceptions include articles intended only for use in industrial/agricultural workplaces, articles only for outdoor use, and measuring devices for laboratory use, except when the phthalate-containing material might be in contact with human skin for more than 10 minutes continuously, or 30 minutes in total, and/or in contact (at all) with human mucous membranes.

European Chemicals Agency (2016).

Annex XV report. Proposal for a restriction. (3,3,4,4,5,5,6,6,7,7,8,8,8-Tridecafluorooctyl)silanetriol and any of its mono-, di- or tri-O-(alkyl) derivatives. 20 April 2016. http://echa.europa.eu/documents/10162/d18b2c60-d874-40ee-b514-c15e61c87b4a

Annex XV Restriction Report. Proposal for a restriction. Four phthalates (DEHP, BBP, DBP, DIBP). Version 1. 1 April 2016. http://echa.europa.eu/documents/10162/b088340c-07bf-41b5-aed7-993166d79a85

…Opinions on DCHP and 3-benzylidene camphor as SVHCs

The majority of ECHA’s Member State Committee (MSC) has agreed that dicyclohexyl phthalate (DCHP) should be considered a substance of very high concern (SVHC) due to its reproductive toxicity and endocrine disruptive effects for human health. They also mostly supported an SVHC proposal for 3-benzylidene camphor due to its endocrine disruptive effects on the environment. The MSC opinions have been sent to the European Commission for decision making.

European Chemicals Agency (2016). MSC sends two SVHC proposals to the Commission for decision making. ECHA/NA/16/24. http://echa.europa.eu/view-article/-/journal_content/title/msc-sends-two-svhc-proposals-to-the-commission-for-decision-making

…ECHA manuals on preparing REACH dossiers

ECHA has released manuals aiming to help registrants in using IUCLID to prepare inquiry dossiers (e.g. for pre-registration), REACH dossiers, product and process orientated research and development (PPORD) dossiers, and downstream user reports.

European Chemicals Agency (2016). Manuals.

How to prepare a downstream user report. Version 1.0. https://echa.europa.eu/documents/10162/22308542/manual_du_report_en.pdf

How to prepare an inquiry dossier. Version 1.0. https://echa.europa.eu/documents/10162/22308542/manual_inquiry_en.pdf

How to prepare REACH and PPORD dossiers. Version 1.0. https://echa.europa.eu/documents/10162/22308542/manual_regis_and_ppord_en.pdf

…Other items of interest

List of REACH guidance documents to be updated before the 31 May 2018 REACH deadline now available. http://echa.europa.eu/view-article/-/journal_content/title/check-which-reach-guidance-will-still-be-updated


Draft updates to the guidance on information requirements and chemical safety assessment (IR&CSA):

  • Chapter 6 (QSARs and grouping of chemicals; appendix R6-1 on recommendations for nanomaterials)
  • Chapter R.7a (endpoint-specific guidance; parts on repeated dose toxicity, and appendix R7‑1 on recommendations for nanomaterials)
  • Chapter R.7b (endpoint-specific guidance; PBT/vPvB aspects, and appendix R7‑1 on recommendations for nanomaterials)
  • Chapter R.7c (endpoint-specific guidance; PBT/vPvB aspects, and appendix R7-2 on recommendations for nanomaterials)
  • Chapter R.11 (PBT/vPvB assessment)
  • Part C (PBT/vPvB assessment)



Updated appendices relevant to nanomaterials are also available for the guidance on registration. http://echa.europa.eu/support/guidance/consultation-procedure/ongoing-reach


Testing proposals involving vertebrate animals: ECHA requests information from third parties on eleven substances including melamine and asphalt (by 1 or 15 July 2016). http://echa.europa.eu/information-on-chemicals/testing-proposals/current


The above items were taken from the July 2016 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here)

News Home Guest Write For Us? Contact Us