…Proposals for the harmonised classification and labelling of five chemicals

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 submitted recently by the Dutch, German and UK authorities to standardise the classification and labelling of the following substances:

  • branched dodecylphenol
  • dodemorph
  • dodemorph acetate
  • imidazole
  • pyridaben

European Chemicals Agency.
Proposal for harmonised classification and labelling based on Regulation (EC) No 1272/2008 (CLP Regulation) Annex VI, Part 2. Phenol, dodecyl-, branched. Version 4, 10 October 2012.

Proposal for harmonised classification and labelling based on Regulation (EC) No 1272/2008 (CLP Regulation) Annex VI, Part 2. Dodemorph. Version 3, July 2012.

http://echa.europa.eu/documents/10162/7c6dc8ca-9a12-4902-b941-90f1b4393197

Proposal for harmonised classification and labelling based on Regulation (EC) No 1272/2008 (CLP Regulation) Annex VI, Part 2. Dodemorph acetate. Version 3, July 2012.

http://echa.europa.eu/documents/10162/46fe5bcf-b7f2-4c83-b6ab-b6848f7ebbb3

Proposal for harmonised classification and labelling based on Regulation (EC) No 1272/2008 (CLP Regulation) Annex VI, Part 2. Imidazole. Version 1, 13 November 2012.

http://echa.europa.eu/documents/10162/142cc46a-d1f3-44b6-a66e-da1e3b0a60b8

Proposal for harmonised classification and labelling based on Regulation (EC) No1272/2008 (CLP Regulation) Annex VI, Part 2. Pyridaben. Version 3, September 2012.

http://echa.europa.eu/documents/10162/9b0ecefb-88fb-4fa8-999a-186d20febef7

…RAC (ECHA’s Committee for Risk Assessment) adopts opinions on the harmonised classification and labelling of 15 chemicals…

As announced in a December 2012 news alert (ECHA/NA/12/61), RAC has considered proposals from the Austrian, Danish, Dutch, French, German and UK authorities to harmonise the classification and labelling of 15 chemicals. RAC agreed with
the following proposals on classification and labelling:

  • formaldehyde (already classified as acutely toxic following oral, dermal or inhalation exposure, corrosive and sensitising to the skin, and suspected of causing cancer) as suspected of causing genetic effects (Muta. 2).
  • 3-iodo-2-propynylbutylcarbamate (IPBC) as acutely toxic following oral or inhalation exposure, sensitising to
    skin, severely damaging to the eye, and toxic to the aquatic environment following acute or chronic exposure.
  • styrene (already classified as flammable when a liquid or vapour, harmful if inhaled, irritating to the skin, and seriously irritating to the eye) as damaging to the hearing organs following prolonged or repeated exposure by inhalation, and suspected of damaging the unborn child (Repr. 2).
  • methyl-2,5-dichlorobenzoate as harmful if swallowed, toxic to aquatic life with long-lasting effects, and
    having narcotic effects after a single exposure.
  • tetrahydrofurfuryl alcohol (THFA) (already classified as seriously irritating to the eye) as a substance which may damage fertility and the unborn child (Repr. 1B).
  • cycloxydim as flammable and a reproductive toxicant suspected of damaging the unborn child (Repr.  2).
  • (1-methylethylidene)di-4,1-phenylene tetraphenyl diphosphate (Fyrolflex) to remove the existing classification as
    hazardous to the aquatic environment, with possible long-lasting harmful effects on aquatic life.
  • tetrakis (2,6-dimethylphenyl)-m-phenylene biphosphate (PX-200) to remove the existing classification as hazardous to the aquatic environment, with possible long-lasting harmful effects on aquatic life (it is also currently classified as sensitising to skin).
  • fenpyrazamine as toxic to aquatic life with long-lasting effects.
  • etofenprox as having effects on or via lactation, and very toxic to aquatic life with long-lasting effects.
  • cis-tricos-9-ene(muscalure) as sensitising to skin.
  • dimethyltin dichloride (DMTC) as a reproductive toxicant suspected of damaging the unborn child (Repr. 2), harmful if swallowed or in contact with skin, fatal if inhaled, corrosive to the skin and eyes, and damaging to the nervous and immune systems after repeated exposure. RAC also concluded that DMTC should be labelled as corrosive to the respiratory tract.
  • dimethyltin bis(2-ethylhexylmercaptoacetate) (DMT EHMA) as a reproductive toxicant suspected of damaging the unborn child (Repr. 2), harmful if swallowed, sensitising to skin, and damaging to the nervous and immune systems after repeated exposure.
  • benzoic acid as irritating to the skin, seriously damaging to the eye, and damaging to the lungs after repeated exposure by inhalation.
  • ethephon (already classified as acutely toxic following inhalation or dermal exposure, causing skin burns and eye damage, and potentially harmful to aquatic life with long-lasting effects) as acutely toxic through the oral route. RAC additionally concluded that Ethephon should be classified as harmful to aquatic life with
    long-lasting effects, and labelled as corrosive to the respiratory tract.

RAC disagreed with the following…

  • formaldehyde as known to have carcinogenic potential for humans (Carc. 1A); instead, RAC
    proposed that formaldehyde is presumed to have carcinogenic potential for
    humans (Carc. 1B).
  • IPBC as causing respiratory irritation after single exposure; RAC instead proposed that IPBC be classified as causing damage to the larynx following prolonged or repeated exposure by inhalation.
  • etofenprox as toxic to the liver and kidneys after repeated exposure.

http://echa.europa.eu/web/guest/view-article/-/journal_content/c89bdb13-09e9-497c-8e73-ddae13a842c8

…RAC evaluates the toxicity of epoxiconazole at the request of ECHA’s Executive Director

Following its 2010 opinion adopting a Swedish proposal for the harmonised classification of epoxiconazole as a presumed human reproductive toxicant which may damage fertility or the unborn child, RAC has assessed additional reproductive
toxicity information submitted by industry. Its existing opinion was confirmed.

http://echa.europa.eu/web/guest/view-article/-/journal_content/c89bdb13-09e9-497c-8e73-ddae13a842c8

…RAC concludes on the restriction of Chromium VI in leather compounds

RAC agreed with a Danish restriction proposal for chromium(VI) in leather compounds. Following consultation, the
wording of the restriction was amended to better cover all leather articles of
concern.

http://echa.europa.eu/web/guest/view-article/-/journal_content/c89bdb13-09e9-497c-8e73-ddae13a842c8

…54 new Substances of Very High Concern (SVHCs) added to Candidate List for authorisation

As announced in an ECHA Press Release (ECHA/PR/12/39), 54 SVHCs have been added to the Candidate List for authorisation, bringing the total number of substances up to 138. Five of these new additions are classified as persistent,
bioaccumulative and toxic (PBT) and/or very persistent and very bioaccumulative (vPvB), 44 are carcinogenic, mutagenic and/or toxic to reproduction (CMR), and the remaining five are of an “equivalent level of concern” (and include three
probable respiratory sensitisers and two chemicals linked to endocrine disruption). A decision will be made later as to whether these chemicals will be subject to authorisation. ECHA reminds companies that they may have legal
obligations resulting from these additions to the list.

http://echa.europa.eu/view-article/-/journal_content/b5d76d7f-7b28-4081-bd5c-9500e01e1ab2

 

…ECHA Practical Guide on qualitative human health assessment

ECHA’s fifteenth Practical Guide provides advice on performing qualitative risk characterisations for human health effects without an established threshold (often applying to irritants/corrosives, sensitisers, carcinogens, mutagens and
reproductive toxicants). Appropriate tools and methodologies are described, as well as clear documentation into a chemical safety report. This accompanies an update to part E of ECHA’s guidance on information requirements and chemical
safety assessment (IR&CSA) regarding qualitative risk characterisation for health hazards.

European Chemicals Agency.

Practical guide 15: how to undertake a qualitative human health assessment and document
it in a chemical safety report. ECHA-12-B-49-EN. November 2012.

http://echa.europa.eu/documents/10162/13655/pg_15_qualitative-human_health_assessment_documenting_en.pdf

Guidance on information requirements and chemical safety assessment. Part E: risk characterisation. ECHA-12-G-16-EN. Version 2.0. November 2012.

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

…Updated guidance on reporting robust study summaries

ECHA has updated its Practical Guide 3 (how to report robust study summaries) to reflect recent updates to the guidance on IR&CSA (sub-chapter R.7.1 – see article below). New and revised OECD Test Guidelines made available since the
2010 Practical Guide have also been considered.

European Chemicals Agency. Practical guide 3: how to report robust study summaries.
Version 2.0. November 2012.

http://echa.europa.eu/documents/10162/13643/pg_report_robust_study_summaries_en.pdf

 

…ECHA guidance on information requirements for physicochemical properties

ECHA has updated sub-chapter R.7.1 (within R.7a) of its guidance on IR&CSA. The chapter provides specific guidance on the various physicochemical end points for which information is required by REACH.

European Chemicals Agency. Guidance on information requirements and chemical safety assessment. Chapter R.7a: endpoint specific guidance. Version 2.0. November 2012.

http://echa.europa.eu/documents/10162/13632/information_requirements_r7a_en.pdf

CSR illustrative example updated with IUCLID and Chesar data files

ECHA’s illustrative CSR demonstrates the assessment of a hypothetical organic compound, exemplifying how to describe uses, assess hazards, estimate exposure and build exposure scenarios for chemicals to be registered under REACH in a
format consistent with REACH Annex I. It has recently been updated, with IUCLID and Chesar data files now available.

European Chemicals Agency. Chemical Safety Report. An illustrative example. ECHA-12-G-03-EN. November 2012

http://echa.europa.eu/support/practical-examples-of-chemical-safety-reports

…Existing Substances Regulation (ESR) reports now available on ECHA website

Before REACH came into force, chemicals were controlled by a number of regulations and directives, including the ESR (Council Regulation (EEC) No 793/93). As part of this regulation, the Commission drew up lists of priority substances requiring immediate attention due to their potential to adversely affect human health or the environment. Four such lists, containing a total of 141 chemical substances, were drawn up between 1994 and 2007. Overviews of the risk
assessments performed on these chemicals by Member States are now available on the ECHA website, and include European Union risk assessment reports (RARs).

European Chemicals Agency. Information from the Existing Substances Regulation.

http://echa.europa.eu/information-on-chemicals/information-from-existing-substances-regulation

 

…Other items of interest

The Member State Committee identifies the first respiratory sensitisers as substances of very high concern.

http://echa.europa.eu/view-article/-/journal_content/aa39c887-b663-43e6-a92d-ee86661fa4a1

JRC and ECHA agree to cement their cooperation by signing a collaboration agreement.

http://echa.europa.eu/view-article/-/journal_content/375128cb-c3b7-411c-a0e0-63c4103445de

ECHA publishes corrigenda of Chapters R7b, R7c, R8, R11, R14, R19 and R20 of the IR&CSA guidance.

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

Corrigendum published for the guidance for Annex V (exemptions from the obligation to register), and
available in 22 EU languages.

http://echa.europa.eu/guidance-documents/guidance-on-reach

Corrigendum to Part D of the IR&CSA Guidance available in 22 EU languages.

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

Corrigendum to the Exposure Scenario Format in Part D and Part F of the IR&CSA Guidance available in 22 EU languages.

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

First wave of test proposals for substances examined by ECHA.

http://echa.europa.eu/web/guest/view-article/-/journal_content/adee7857-f7cd-4842-b7e2-0da69e8a1f15

Preliminary results of enforcement project point to high rates of non-compliance among chemical formulators.

http://echa.europa.eu/web/guest/view-article/-/journal_content/e2e8f996-ed11-4210-9445-f85dc6e13ca7

ECHA starts publishing dossier evaluation decisions.

http://echa.europa.eu/view-article/-/journal_content/title/echa-starts-publishing-dossier-evaluation-decisions

ECHA to start publishing comments during harmonised classification and labelling (CLH) public consultations.

http://echa.europa.eu/web/guest/view-article/-/journal_content/title/echa-to-start-publishing-comments-during-clh-public-consultations

The ECHA Committee for Socio-economic Analysis (SEAC) concludes on scientific opinions for two restriction proposals.

http://echa.europa.eu/web/guest/view-article/-/journal_content/e14a8add-b03d-4705-95d8-8600b7c5b10c

ECHA launches a public consultation on SEAC’s draft opinion on restricting chromium(VI) in leather articles.

http://echa.europa.eu/web/guest/view-article/-/journal_content/2774c84c-5757-4746-b0ef-ff43c3e219ae

New web form launched for notifying substances of very high concern (SVHCs) in articles.

http://echa.europa.eu/view-article/-/journal_content/6244f691-4a80-460b-9cb0-f704492fc7a2

Six-month moratorium on Guidance and IT-tool updates: 1 December 2012 to 31 May 2013.

http://echa.europa.eu/view-article/-/journal_content/d88226de-9a1b-4579-b0e1-9a8bf03e63ee

Last update of REACH-IT ahead of the 2013 deadline.

http://echa.europa.eu/web/guest/view-article/-/journal_content/0ef9bf18-f6bd-433a-9f6d-ee9065721b7a

Updated FAQ (frequently asked questions) for Chesar 2.1 available.

http://chesar.echa.europa.eu/web/chesar/view-article/-/journal_content/56_INSTANCE_M6zz/title/faq-for-chesar-2-1-have-been-updated

Testing proposals involving vertebrate animals: request for information from third parties on N-(cyclohexylthio)phthalimide (deadline 31 January 2013).

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

 

The above items were taken from the January–February 2013 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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