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ECHA Weekly - 14 February 2018

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Inspectors find phthalates in toys and asbestos in second-hand products

In an EU/EEA-wide project of ECHA’s Enforcement Forum, inspectors found hundreds of consumer products containing illegal amounts of restricted chemicals. Every fifth toy inspected contained high levels of restricted phthalates.

Inspectors in 27 European countries checked 1 009 mixtures, 4 599 articles and 17 substances. Overall, out of 5 625 targeted product checks, 18 % did not comply with the applicable restrictions.

Press release | REF 4 report
REACH 2018
REACH 2018: last minute advice to registrants
8 March 2018, 11:00–12:00 EET (Helsinki time)

Join our webinar to get last-minute advice on how to successfully submit your REACH registration dossier and to ask our experts your
questions directly.

Register

Watch a webinar: Guided dossier preparation in IUCLID

The webinar covers a feature for helping SMEs to prepare IUCLID dossiers using the IUCLID Cloud. This feature, named ‘Guided dossier preparation for REACH 2018’, presents SMEs with a series of well-defined tasks to complete based on the type of dossier they intend to submit to ECHA. The guided approach includes task-specific help and links to relevant guidance documents and texts.

Presentation and recording
REACH
Have your say on the definition of an SME

The European Commission is reviewing the  definition of an SME to ensure that it remains fit for purpose and meets its objectives in the current economic environment, and to evaluate the need for possible changes. The survey is available in all EU languages.

The SME definition is relevant for European administrative exemptions and reduced fees, including reduced fees under REACH, CLP and BPR.

Participate in the public consultation by 6 May 2018.

Participate | European Commission - what is an SME?

Have your say on applications for authorisation

ECHA has launched public consultations on three applications for authorisation for the following substances and uses:
  • sodium dichromate (EC 234-190-3) used as a corrosion inhibitor in ammonia absorption deep cooling systems, applied for the dewaxing and deoiling process steps of petroleum raffinate;
  • bis(2-methoxyethyl) ether (Diglyme) (EC 203-924-4) used as a solvent for the synthesis of the anti-HIV active pharmaceutical ingredient (API) dapivirine;
  • dibutyl phthalate (DBP) (EC 201-557-4) used in the manufacture of ceramic sheets for the production of multi-layer ceramic capacitors.

More information about the uses that authorisation is applied for - including the description of the function of the substance, exposure scenarios, possible alternatives identified by the applicants, and socio-economic information - is available on ECHA’s website.

The deadline for comments is 11 April 2018, 23:59 (Helsinki time).

Applications for authorisation - current consultations

Committees’ opinion on an application for authorisation now available

The consolidated opinion of the Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) for a use of 1,2-dichloroethane (EDC) (EC 203-458-1; CAS 107-06-2) by Microbeads AS is available on our website.

Opinion

Further substances assessed by authorities

The Public Activities Coordination Tool (PACT) has been updated with information on three substances that are undergoing hazard assessment or risk management option analysis by authorities.

Public Activities Coordination Tool

New substance evaluation conclusion published

One new substance evaluation conclusion document is now available on ECHA’s website for 7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate (EC 219-207-4; CAS 2386-87-0), added to the CoRAP list in 2013 and evaluated by Ireland.

Community rolling action plan | Substance evaluation
CLP
Public consultation on harmonised classification and labelling

ECHA is looking for comments on the harmonised classification and labelling proposals for:

 
  • 2-(4-tert-butylbenzyl)propionaldehyde (lysmeral) (EC 201-289-8; CAS 80-54-6). It is an industrial chemical used in consumer products including personal care, washing and cleaning products, as well as an active substance (e.g. in disinfectants, pest control products). It has no existing harmonised classification and labelling in Annex VI to CLP. Comments are invited on the reproductive toxicity hazard class.
  • dibenzo[def,p]chrysene; dibenzo[a,l]pyrene (EC 205-886-4; CAS 191-30-0). It is a chemical contaminant from the family of polycyclic aromatic hydrocarbons (PAHs). It is released into the environment during incomplete combustion or pyrolysis of organic matter, an important source for human exposure. It has been detected in consumer products and articles such as toys, tool handles, bicycle grips, shoes, and sports equipment. It has no existing harmonised classification and labelling in Annex VI to CLP. Comments are invited on germ cell mutagenicity and carcinogenicity hazard classes.
  • 2,4-dinitrophenol (EC 200-087-7; CAS 51-28-5). It is an industrial chemical used as a monomer. It has also been misused as a weight control drug causing human poisonings. It has no existing harmonised classification and labelling in Annex VI to CLP. Comments are invited on acute toxicity specific and target organ toxicity - repeated exposure hazard classes.
  • 4,5-dichloro-2-octyl-2H-isothiazol-3-one; [DCOIT] (EC 264-843-8; CAS 64359-81-5) is an active substance used in biocidal products as a preservative and anti-fouling agent. It has no existing harmonised classification and labelling in Annex VI to CLP. Comments are invited on all physical, human health and environment hazard classes except aspiration hazard and hazardous to the ozone layer.
  • phosphine (phosphane) (EC 232-260-8; CAS 7803-51-2). It is an active substance used in plant protection products and in biocidal products releasing phosphine. It is also an industrial chemical used in the manufacture of electrical, electronic and optical equipment. It has an existing harmonised classification and labelling in Annex VI to CLP. Comments are invited on the hazard class acute toxicity via inhalation route.
  • pirimiphos-methyl (ISO); O-[2-(diethylamino)-6-methylpyrimidin-4-yl] O,O-dimethyl phosphorothioate (EC 249-528-5; CAS 29232-93-7). It is an active substance used in plant protection products as a broad-spectrum insecticide. It has an existing harmonised classification and labelling in Annex VI to CLP. Comments are invited on the hazard classes acute toxicity via oral route, germ cell mutagenicity, carcinogenicity, specific target organ toxicity - repeated exposure and hazardous to the aquatic environment.
    A synchronous public consultation on the assessment report for pirimiphos-methyl (ISO) as an active substance in plant protection products is ongoing on the website of the European Food Safety Authority (
    EFSA).

The deadline for comments is 13 April 2018, 23:59 EET (Helsinki time).

Give comments
Biocides
List of notifications updated
 
An updated list of those substance and product-type combinations for which a compliant notification for inclusion in the review programme has been made is available. It also includes the names of the notifying companies to help you collaborate when submitting an application for approval of the active substance and to help avoid unnecessary testing on animals.
 
List of compliant notifications
 
Want to keep using copper in antifouling products?
 
The time is approaching to notify your interest in seven active substance and product-type combinations to get them approved in the biocides review programme. Check the substance-specific deadlines and notify your interest through the biocides IT tool R4BP 3.

Upcoming deadlines

Public consultation on derogation to the exclusion criteria for cholecalciferol

Substances that normally should not be approved as active substances may be used if they meet one or more of the following derogation criteria: exposure is negligible; the active substance is essential to prevent a serious danger to human or animal health or the environment; or, not approving the substance would have a disproportionate negative impact on society when compared to the risks.

Give your comments on whether the conditions for derogation are met for cholecalciferol by 7 April 2018.

Give comments | BPC opinion
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