…REACH 2018 roadmap published by ECHA

ECHA’s 2018 roadmap outlines relevant milestones and timings planned in the run-up to the REACH registration deadline (of 31 May 2018) for substances manufactured or imported into Europe in volumes of between 1 and 100 tonnes per year.

European Chemicals Agency. ECHA’s REACH 2018 roadmap. ECHA-15-R-01-EN. 14 January 2015. http://echa.europa.eu/documents/10162/13552/reach_roadmap_2018_web_final_en.pdf See http://echa.europa.eu/reach-2018 for REACH 2018 webpages.

…Updated guidance on PBT/vPvB assessment from ECHA

ECHA has finalised updates to its guidance on information requirements and chemical safety assessment (IR&CSA). The updates relate to the assessment of a chemical’s potential to be persistent, bioaccumulative or toxic, or very persistent and very bioaccumulative, in the environment. Chapters R.7b, R.7c and R.11, and Part C, are affected.

European Chemicals Agency. Guidance on information requirements and chemical safety assessment. Chapter R.7b: Endpoint specific guidance. Version 2.0, November 2014. ECHA-14-G-05-EN. http://echa.europa.eu/documents/10162/13632/information_requirements_r7b_en.pdf

Chapter R.7c: Endpoint specific guidance. Version 2.0, November 2014. ECHA-14-G-06-EN. http://echa.europa.eu/documents/10162/13632/information_requirements_r7c_en.pdf

Chapter R.11: PBT/vPvB assessment. Version 2.0, November 2014. ECHA-14-G-07-EN. http://echa.europa.eu/documents/10162/13632/information_requirements_r11_en.pdf

Part C: PBT/vPvB assessment. Version 2.0, November 2014. ECHA-14-G-04-EN. http://echa.europa.eu/documents/10162/13643/information_requirements_part_c_en.pdf



…Guidance document on structured short titles for exposure scenarios

A report produced under the umbrella of ENES provides a harmonised approach to creating structured short titles for exposure scenarios, and contains guidelines on implementing this approach in the software applications used to compile and issue extended safety data sheets (SDSs).

Exchange Network on Exposure Scenarios. European Chemicals Agency (ECHA), Downstream Users of Chemicals Co-ordination group (DUCC), European Chemical Industry Council (Cefic). Structured short titles in exposure scenarios for communication. Instructions to define unambiguous exposure scenario short titles. Version 1.0. November 2014. http://www.ducc.eu/documents/StructuredShortTitles%20for%20publication%20041114%20final.pdf

…ECHA releases 2014 CMR report

According to ECHA’s recent CMR report, companies are adhering well to the harmonised classification and labelling of substances with carcinogenic, mutagenic or reprotoxic properties. In addition, ECHA has identified over a thousand CMR substances which potentially merit further regulatory action (e.g. harmonised classification and/or identification as a substance of very high concern), and is prioritising these for appropriate risk management actions.

European Chemicals Agency. 2014 CMR Report. ECHA-15-R-02-EN. 19 January 2015. http://echa.europa.eu/documents/10162/13562/cmr_report_2014_en.pdf

…Dutch authority assesses quality of industry DNELs

For 18 substances evaluated under REACH, RIVM experts have compared worker inhalation derived no-effect levels (DNELs) estimated by industry to those that they themselves have determined (using the same data provided by the REACH registrants and following the ECHA guidance). For three of the 18 substances, RIVM considered a derived minimal-effect level (DMEL, indicating concerns over non-threshold toxicity e.g. genotoxicity) to be more appropriate than a DNEL. For eight of the remaining 15 substances, the industry-derived DNELs were at least 10-fold higher than RIVM’s. The significantly lower margins of safety provided by the industry assessments were attributed to different interpretations of the toxicology data (leading to different points of departure), and the use of smaller assessment factors.

RIVM calls for more transparency in the derivation of D(M/N)ELs. In order to improve the estimates provided by industry, it suggests the need for (amongst other things) quality standards concerning the competences of those responsible.

[Please do not hesitate to contact bibra if you require further help in this area; we have worked on hundreds of successful REACH lead registrations, and can help in all stages of REACH registration and beyond.]

Schenk L et al. (2014). Evaluation of worker inhalation DNELs. National Institute for Public Health and the Environment (RIVM). RIVM Letter report 110001001/2014. http://www.rivm.nl/bibliotheek/rapporten/110001001.pdf



…Proposals for harmonised classification and labelling

Under Regulation (EC) 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 ECHA organises a public consultation period of 45 days. Under this scheme, proposals have been submitted by the Austrian and Irish authorities to standardise the classification and labelling of cyproconazole, 4-(morpholin-4-ylmethyl)morpholine, and the reaction products of paraformaldehyde and 2-hydroxypropylamine (at ratios of 1:1 and 3:2).

European Chemicals Agency. CLH reports. Proposals for harmonised classification and labelling based on Regulation (EC) No. 1272/2008 (CLP Regulation), Annex VI, Part 2.

Cyproconazole. Version 1. 2014. http://echa.europa.eu/documents/10162/b3403d91-98a1-44a5-8b29-d50b946ddfac

4-(Morpholin-4-ylmethyl)morpholine. Version 2. 15 September 2014. http://echa.europa.eu/documents/10162/d404e0c2-cbb3-4cbf-a424-f10fde00357b

Reaction product of paraformaldehyde and 2-hydroxypropylamine (ratio 1:1). Version 2. 12 December 2014. http://echa.europa.eu/documents/10162/7b8242ea-c0fe-45a2-8b9e-6d8629e86f5c Reaction product of paraformaldehyde and 2-hydroxypropylamine (ratio 3:2). Version 2. 15 September 2014. http://echa.europa.eu/documents/10162/a26939c3-9b83-43dd-8bc7-2048a9d6827c

…RAC adopts opinions on harmonised classification and labelling

As announced in a December 2014 news alert, RAC (the Committee for Risk Assessment) has considered proposals (from the Dutch, German, French, Polish, Spanish, Swedish and UK authorities, and from ECHA) to harmonise the classification and labelling of:

  • acetochlor
  • benzovindiflupyr
  • Bordeaux mixture (reaction products of copper sulphate with calcium dihydroxide)
  • chlorsulfuron
  • copper
  • copper(II) carbonate – copper(II) hydroxide (1:1)
  • copper(II) hydroxide
  • copper(I) oxide
  • copper(II) oxide
  • copper oxychloride
  • copper sulphate pentahydrate
  • copper thiocyanate
  • dicyclohexylphthalate (DCHP)
  • diisobutylphthalate (DIBP)
  • E-glass and glass microfibres of representative composition
  • fluopyram
  • geranonitril
  • pencycuron
  • pirimicarb
  • tetracopper hexahydroxide sulphate and its hydrate
  • tert-butyl hydroperoxide (TBHP)
  • tetrapropylphenol (TPP)
  • triflumizole

European Chemicals Agency (2014). The Committee for Risk Assessment adopts 23 opinions for harmonised classification and labelling. ECHA/NA/14/55. http://echa.europa.eu/view-article/-/journal_content/title/the-committee-for-risk-assessment-adopts-23-opinions-for-harmonised-classification-and-labelling



…RAC and SEAC agree on restriction proposals and opinions on authorisation

ECHA’s Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) have recently considered some restriction proposals and applications for authorisation.

RAC adopted its opinions supporting the restriction of chrysotile asbestos, and cadmium and its compounds in paints, and SEAC also drafted its own opinions on these restrictions. SEAC adopted opinions on the restriction of cadmium and its compounds in artists’ paints, and on the restriction of 1-methyl-2-pyrrolidone (NMP). RAC, meanwhile, considered a Dutch (RIVM) report on the risks to consumer health posed by an increased concentration limit of benzene in natural gas.

Both Committees also agreed on several applications for the authorisation of:

  • bis(2-ethylhexyl) phthalate (DEHP)
  • diarsenic trioxide
  • dibutyl phthalate (DBP)
  • hexabromocyclododecane (HBCDD)
  • lead sulfochromate yellow (C.I. pigment yellow 34) and lead chromate molybdate sulphate red (C.I. pigment red 104)
  • trichloroethylene

European Chemicals Agency (2014). RAC and SEAC agree on restriction proposals and evaluate applications for authorisation, agreeing on 43 draft opinions for individual uses. ECHA/NA/14/52. http://echa.europa.eu/view-article/-/journal_content/title/rac-and-seac-agree-on-restriction-proposals-and-evaluate-applications-for-authorisation

Comments are welcomed on the two SEAC draft opinions by 8 February 2015. Reports can be accessed and commented upon at http://echa.europa.eu/restrictions-under-consideration



…ECHA adds six new SVHCs to its Candidate List and updates entry for bis(2-ethylhexyl) phthalate (DEHP)

As announced in a recent press release (ECHA/PR/14/18), the total number of substances on ECHA’s Candidate list for authorisation has been brought up to 161 by the addition of the following six substances of very high concern (SVHCs):

  • cadmium fluoride
  • cadmium sulphate
  • DOTE (2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate)
  • reaction mass of MOTE (2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate) and DOTE
  • UV-320 (2-benzotriazol-2-yl-4,6-di-tert-butylphenol)
  • UV-328 (2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol)

The new additions are classified as carcinogenic, mutagenic and/or toxic to reproduction (CMR), persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), and/or of an “equivalent level of concern”.

Meanwhile, the existing entry for DEHP was modified to reflect the potential for this chemical to have serious effects on the environment due to its endocrine-disrupting properties.

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 (2014). Six new substances of very high concern (SVHCs) added to the Candidate List and one entry updated. ECHA/PR/14/18. http://echa.europa.eu/view-article/-/journal_content/title/six-new-substances-of-very-high-concern-svhcs-added-to-the-candidate-list-and-one-entry-updated



…Proposed restriction of perfluorooctanoic acid (PFOA) and related substances

A recent Annex XV report submitted by the German and Norwegian authorities proposes a restriction on the manufacture, use or placing on the market of PFOA (and related compounds), either as a substance by itself, or when present in other substances at concentrations of 2 ppb or more. Articles (or parts thereof) containing the substance at 2 ppb or more shall also not be placed on the market.

European Chemicals Agency. Annex XV restriction report. Proposal for a restriction. Perfluorooctanoic acid (PFOA), PFOA salts and PFOA-related substances. Version number 1.0. 17 October 2014. http://echa.europa.eu/documents/10162/e9cddee6-3164-473d-b590-8fcf9caa50e7



…Other items of interest

OECD QSAR Toolbox Version 3.3 now available (please see the International section of this issue of Toxicology and Regulatory News for more information).http://echa.europa.eu/view-article/-/journal_content/title/qsar-toolbox-3-3-now-available


ECHA has finalised its guidance on scientific research and development (SR&D) and product and process orientated research and development (PPORD), and published an associated ‘guidance in a nutshell’ document.http://echa.europa.eu/view-article/-/journal_content/title/updated-guidance-to-support-r-and-d-and-innovation
Draft updated text of the guidance on the compilation of safety data sheets (version 3.0) sent to Partner Expert Group (PEG) for consultation.http://echa.europa.eu/documents/10162/13564/guidance_on_sds_v3_draft_to_peg_en.pdf


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


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