ECHA Committees Adopt Final Opinions On TCE Authorisation Applications

« Echa’s Risk Assessment Committee (Rac) and Socio-economic Analysis Committee (Seac) both adopted final Opinions on an application for the use of trichloroethylene (TCE) for industrial degreasing, at their meetings, last week.
The application, made by DOW Deutschland Anlagengesellschaft mbH, is for use of the compound for vapour degreasing of industrial parts, in closed systems, where specific requirements exist.

TCE is a carcinogenic substance of very high concern (SVHC) with a sunset date of 21 April 2016.
Rac considered 13 applications for TCE authorisation, covering 19 uses, at its June meeting. These are the last of those Opinions to be finalised by the committees.
They have also adopted final Opinions on the authorisation of the use of lead chromate in pyrotechnical delay devices in naval self-protection ammunition. »

Rac meeting agenda :
Rac press release :
Seac meeting agenda :
Seac press release :

Lettre Service National d’Assistance réglementaire Reach-Clp, N° 113- Octobre 2015:

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ECHA Committee Gives ‘Nuanced’ View On Proposed BPA Restriction

« Seac says ban on BPA-containing thermal paper ‘unlikely to be proportionate’
A proposal to ban thermal paper, containing bisphenol A, from the EU market received a mixed response, last week, from Echa’s Socio-Economic Analysis Committee (Seac).

According to Echa, the committee’s draft Opinion says the proposed ban, which would take the form of a REACH restriction, was “unlikely to be proportionate from an economic efficiency perspective”.
But Seac also decided it might have “favourable distributional and affordability considerations”, the agency said.

The Opinion was « nuanced », chairman Tomas Oberg told Chemical Watch.
A 60-day public consultation on the draft Opinion was due to be launched on 16 September. The committee’s final Opinion is expected in December.
Earlier this year, the proposed ban received the backing of Echa’s Risk Assessment Committee on the grounds that thermal paper products, such as till receipts, presented an uncontrolled risk to workers.

Once Seac has agreed its final Opinion – which may be different from the draft – it will be sent, along with Rac’s, to the European Commission, which then has three months to prepare a proposal for amending REACH Annex XVII – the list of restrictions.

When doing so, the Commission can depart from the Opinions submitted by Rac and Seac, but must explain its reasons for doing so.
It is not obliged to go back to those committees with a restriction text, but may proceed to submit it to the REACH Committee of member state representatives. »

Article by Geraint Roberts
Echa press release :

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Proposed EU Ban On Deca-BDE Moves Forward

« Further exemptions listed for vehicles, machinery spare parts, military aircraft
A proposed EU ban on the placing on the market of the brominated flame retardant, deca-BDE, as a substance in mixtures and articles, advanced another step, last week, when Echa’s Socio-Economic Analysis Committee adopted its final Opinion.

The committee reiterated the view expressed in its draft Opinion that such a ban, which is proposed as a restriction under the REACH Regulation, is the most appropriate way to address the risks posed by the substance.

It said additional exemptions should apply to deca’s use in military aircraft, road vehicles, spare parts for machinery, agricultural and forestry vehicles.
The committee has already said the restriction should not apply to the restriction for electrical and electronic equipment because this use of deca-BDE is already banned under the EU Directive on the restriction of hazardous substances (RoHS).

The proposed restriction has already been backed by Echa’s Risk Assessment Committee because of concern about its persistence and toxicity, and its global distribution through the atmosphere . »

Source :

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ECHA’s MSC Pushes Optimised Animal Use In Testing Proposals

« Committee says two genotox tests can be conducted on the same animals
Echa’s Member State Committee (MSC) has for the first time requested that a registrant conduct two in vivo tests on the same animals.

At its meeting last week, the the committee agreed a compliance check on the dossier for n-isopropyl-n’-phenyl-p-phenylenediamene.

In order to fill a data gap in the dossier, it decided the registrant must conduct two in vivo assays for genetic damage, and that it should combine these and use the same animals.

They are:

• the comet assay OECD TG 489; and
• the micronucleus assay OECD TG 474. in order to fill a data gap in the dossier, but that it should combine these assays and use the same animals.

“This is a very good way of optimising test procedures and was important from an animal welfare point of view,” MSC chairman Watze de Wolf said. The decision will support one of the chief aims of REACH: is to reduce, refine and replace animal use in chemical testing.

The committee also agreed the technical details of a testing proposal examination on the dossier for 3-methoxy-3-methylbutan-1-ol, and discussed a compliance check on the dossier for 2,2’-dimethyl-4,4’-methylene-bis(cyclohexylamine). On the latter, the committee agreed not to pursue – at this moment under this compliance check – the proposals for amendment regarding the information requests for simulation degradation testing.

The MSC also considered two draft decisions on substance evaluations:

• 3,3’-dimethylbiphenyl-4,4’-diyl diisocyanate. Known as TODI, the French competent authority is looking at this.

It was listed for substance evaluation due to concerns that it is a potential CMR (carcinogen, mutagen or reproductive toxicant) and a potential sensitiser with possible persistent, bioaccumulative and toxic (PBT) properties.

It is used as a monomer in polyurethane manufacture under highly controlled conditions. There is potential for the formation of a degradation product, known as TODA, which has a harmonised classification as a 1B carcinogen. TODA, and potentially other degradation products stemming from TODI, might also be released from the polymer or during use of the finished articles.
To determine whether this substance can be safely managed, the committee decided to ask the registrant for further information on human exposure to the substance and degradation products. The competent authority will then review the situation and determine whether further consideration by the committee is necessary.

• di-tert-butyl 3,3,5-tri-methylcyclohexidene diperoxide. This is being looked at by the German competent authority.

It is has a wide range of uses in adhesives, sealants and coatings, but has potential PBT or very persistent very bioaccumulative (vPvB) properties.

The substance evaluation showed there is significant uncertainty around its water solubility, and therefore an existing bioaccumulation study may not be sufficiently reliable. Performing a simulation degradation test in surface water may also not be technically feasible. Hence the committee decided to request a water solubility study.

The committee also asked the registrant to perform two simulation degradation tests sequentially. If the first test in surface water turns out to be impossible, the second one in sediment can be carried out immediately.

At the meeting the MSC appointed a rapporteur, co-rapporteur and established a working group for the update of the Community Rolling Action Plan (Corap) in March next year. The rapporteur and working group will prepare the draft Opinion on the Corap, which the committee will discuss and agree upon in meeting in February. »

Article by Philip Lightowlers:
MSC meeting 43 agenda :

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EFSA Reports On Potentially Endocrine Disrupting Pesticides

« The European Food Safety Authority (Efsa) has published an overview of how it has assessed the endocrine-disrupting properties of several pesticide active substances, based on the interim criteria for identifying endocrine disrupting chemicals (EDCs) in the plant protection products (PPP) Regulation.

Since 2014, Efsa has assessed the potential endocrine effects of 15 new pesticide active substances, and 26 applications for renewal.

Efsa says that this number is insufficient to statistically analyse the results, but notes some differences between the application of the PPP criteria and the outcome of its own scientific assessment.

Some substances, for example, did not meet the interim PPP criteria, but Efsa decided their adverse effects could be linked to endocrine mediated mechanisms.

Efsa’s assessments will feed into the screening of potential EDCs, which will be conducted for the European Commission as part of an impact assessment of potential criteria for the identification of EDCs under the biocides and pesticides Regulations .
Lisette van Vliet, senior toxics adviser at health NGO Health and Environment Alliance, said Efsa’s work to assess the endocrine-disrupting properties of pesticides should take into account combined exposure.

“Until pesticides are evaluated not only for their ‘individual’ risk, but also for the health threat arising from the combination of potential endocrine disrupting pesticides and all the other non-pesticide exposures to EDCs, the European Union will not be making anyway headway against this toxic pollution tidal wave,” she said. »

Efsa page:


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EU Commission Consults On Zinc Oxide Restriction, Chloroacetamide Ban

« The European Commission has opened public consultations on its proposals to restrict the use of zinc oxide as a colourant and to ban the use of chloroacetamide in cosmetic products.

The Commission plans to amend the entry for zinc oxide under Annex IV to the cosmetic products Regulation, which lists all approved colourants, to exclude applications that may lead to exposure of the end user’s lungs by inhalation.

Chloroacetamide will be added to the list of substances prohibited in cosmetic products, under Annex II to the Regulation.

The chemical has been classified as toxic for reproduction under the CLP Regulation. The Commission’s Scientific Committee on Consumer Safety has advised against its use in cosmetic products.

For both chemicals, the Commission proposes a nine-month transitional period for withdrawing non-compliant products from the market.
The proposals are open for comments until 24 December. »

Chloroacetamide :
Zinc oxide :

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Biocides Standing Committee Approves MBM, Hexaflumuron

« The EU Standing Committee on Biocidal Products has approved three active substance/product-type combinations:

4,4′-methylenedimorpholine (MBM) for use in preservatives for products during storage (product-type six), and working or cutting fluid preservatives (product-type 13); and

hexaflumuron for use in insecticides, acaricides and products to control other arthropods (product-type 18).

The approvals were voted through at the committee’s meeting on 18 September.
The committee also adopted an implementing decision that anti-viral tissue, impregnated with citric acid, should be regarded as a treated article under the biocidal products Regulation (BPR). This is due to the “prominence” of the public health claim, says the Commission.

A favourable opinion by the committee means the Commission will now formally adopt the proposals. »

Meeting agenda :

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