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REACH restriction submitted on D4/D5 in personal care products by Nick Boley

The UK authorities have submitted their application to CHA for a restriction under REACH on the use of the cosmetic ingredients D4 (octamethylcyclotetrasiloxane) and D5 (decamethylcyclopentasiloxane) in wash-off personal care products. The proposal asks that an upper limit of 0.1% applies to each of these.

These can be determined analytically by gas chromatography-mass spectrometry (GC-MS). A further siloxane in this family, D6 (dodecamethylcyclopentasiloxane), is frequently found in mixtures with D4 and D5, but is not included in the scope of this restriction application.

 

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 Community Rolling Action Plan for 2015 adopted by ECHA by Nick Boley
March 18, 2015, 09:47
Filed under: chemicals, ECHA, REACH/CLP | Tags: , ,

The European Chemicals Agency, ECHA, has agreed with the Member States Committee, the 2015-17 Community Rolling Action Plan (CoRAP).

The plan details that 134 substances are due to be evaluated by Member States over the 2015-17 period, with 48 alone being evaluated this year. These substances have a suspicion that their manufacture and/or use could pose risks to human health and/or the environment. Some of the more common substances being evaluated across various Member States in 2015 are:

  • aluminium chloride
  • phenol
  • octamethyltrisiloxane, decamethyltetrasiloxane  and dodecamethylpenta- siloxane , all suspected by the UK authorities of being persistent, bioaccumulative and toxic (PBT) substances.

 



Definitive ruling on SVHC in Articles issue by Nick Boley
February 19, 2015, 09:59
Filed under: chemicals, ECHA, EU Information, REACH/CLP | Tags: ,

The Advocate General to the European Court of Justice, a senior legal advisor, has issued a ruling stating that companies (manufacturers and importers) have an obligation under REACH to report the presence of substances of very high concern (SVHCs) in articles and this applies to all components incorporated into articles, not the whole article. REACH Article 33 states that companies must inform the European Chemicals Agency (ECHA) if an SVHC is present, totalling over one tonne per producer or importer per year, in a concentration higher than 0.1 % by weight.

A number of member states have considered that the obligations under REACH for companies only applied to the whole (e.g. finished) article. A good example of this would be a car, where SVHCs may be found in some specific components at appropriate concentrations, but overall would be significantly lower.

This means that companies in all member states will need to ascertain the levels of SVHCs in all components used in the assembly of any product, which will require a greater breadth of analytical testing in many cases.



Outputs of ECHA Nanomaterials Workshop Available by Nick Boley
February 17, 2015, 16:34
Filed under: ECHA, EU Information, Nanomaterials | Tags: , ,

The presentations given at a nanomaterials workshop held at the ECHA premises in Helsinki in October 2014 are now available on the ECHA website. The workshop, “Regulatory Challenges in Risk Assessment of Nanomaterials”  covered a range of topics, with a wide range of speakers and delegates attending.  One of the themes which emerged from the workshop was that of the need for measurement strategies to be able to identify nanomaterials according to the proposed EU definition: a material with 50 % or more of particles, by number size distribution, having a size between 1 nm-100 nm. This is needed before risk assessments can be carried out, so we know we are dealing with nanoscale materials specifically.

Some information was presented on methods for characterising and measuring nanoparticles which had been carried out under the EU Framework Programme 7 NanoReg 2 project.

It is encouraging to see that work is progressing towards  metrologically-sound methods being developed for characterisation and measurement of nanomaterials, and that attention is being paid to the practical aspects of defining nanomaterials as part of the overall risk assessment and regulatory process.

 

 



ECHA push for Substance Identity Completeness by Nick Boley
January 22, 2015, 10:52
Filed under: chemicals, ECHA, REACH/CLP | Tags: ,

The European Chemicals Agency (ECHA)  has agreed the first steps of a new approach to improve the completeness check of incoming REACH registrations. It aims to reinforce the automatic completeness check rules on substance identity (SID) information, and will request the identification of the scope of joint registrations with regard to SID information.

This recognises the importance of accurate substance identity data, and the correct and consistent naming of chemical compounds registered under REACH. ECHA wants to work in tandem with the REACH SIDC project, which covers the analysis of substance identity and substance sameness of complex substances in REACH. It is organising a workshop to be held in Brussels on 27-28 April 2015, to which any organisation with an interest in this should attend.

It is very important for companies registering substances under REACH to be able to carry out, or draw on, validated analytical techniques to properly identify a substance, or determine the composition of mixtures and complex substances.

 



ECHA Issues PIC Guidance by Nick Boley
December 15, 2014, 12:42
Filed under: chemicals, ECHA, EU Information | Tags: ,

ECHA, the European Chemicals Agency, has published a guidance document  which explains the obligations under the Prior Informed Consent (PIC) Regulation and gives advice on how to comply with them. The PIC Regulation (EU 649/2012) enforces the Rotterdam Convention on toxic and hazardous chemicals and regulates trade in these substances.

In order to comply with the guidance from ECHA, companies trading in these chemicals as well as enforcement authorities, need to be able to unambiguously identify them. This requires that appropriate laboratory testing may need to be available to confirm the identity of any substance which falls under the scope of this Regulation, and the Convention.



UK seeks restriction on D4 and D5 by Nick Boley
November 11, 2014, 11:29
Filed under: ECHA, Environment/Ecology | Tags: , ,

The UK Government has requested that two siloxanes commonly used in personal care product, namely octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5) be subject to restriction under REACH. A proposal will be submitted in January 2015, based upon the UK competent authority’s research which shows that these compounds are persistent and bioaccumulative in the environment.  It is particularly concerned about the release of these siloxanes into freshwater, leading to a build-up in sediments.

This will be a complex submission, and therefore the European Chemicals Agency, ECHA, has announced that this will be looked at, unusually, by both the Member States Committee (MSC) and the Risk Assessment Committee (RAC) in the first instance, due to its complexity. The background to this is shown here. Manufacturers and importers who have registered these substances with ECHA under REACH dispute that they are persistent and bioaccumulative.

These two substances can be measured in environmental materials – in the USA, the Environmental Protection Agency can determine D4 at levels of 0.037 µg/L by gas chromatography-mass spectrometry (GC-MS).