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EU Regulatory Bulletin I November/December 2014



Belgium, United Kingdom

ECHA has issued a set of five Transitional Guidance documents for the biocidal products Regulation 528/2012 (BPR), regarding the evaluation of environmental risk mitigation measure (RMM) for...

ECHA Publishes five new Biocides Transitional Guidance documents 

ECHA has issued a set of five Transitional Guidance documents for the biocidal products Regulation 528/2012 (BPR), regarding the evaluation of environmental risk mitigation measure (RMM) for disinfectants product types (PT): 1 (Human Hygiene); 2 (Disinfectants and algaecides not intended for direct application to humans and animals); 3 (Veterinary hygiene); 4 (Food and feed area); and 5 (Drinking water)

The aim of these documents is to set possible harmonized RMM's that can be used for all authorisations within the EU.  

Member States competent authorities adopt biocides treated articles guidance 

During their last Competent Authorities (CA) meeting on the 14th November 2014, Member States reached a concensus on the revised note for guidance on treated articles. The document explains that these provisions will apply depending on whether goods "intentionally incorporate" a biocidal product or are treated with a biocidal product. The former concept can be interpreted as a long term effect on the article whereas the latter concept can be interpreted as a short term effect on the article. However in both cases the provisions on treated articles will apply. 

Second, the guidance clarifies the situation in relation to the application of the treated articles provisions to complex articles; e.g. do the foregoing provisions apply if electrical components within the television are treated with a biocidal product to give them protection against the growth of fungi (and no other part of the TV is treated), and that television is then imported into the EU? 

The guidance now states that: 

"The scope of treated articles excludes such biocidal treatments or incorporation of biocides in a substance, mixture or article, or individual constituents thereof, which were made in the course of manufacturing merely in order to perform a specific biocidal function at that stage of the process, but which will not have an intended function in the finished goods as placed on the EU market".

Member States were given until the 21st November to provide final comments and the European Commission is expected to publish the guidance in the upcoming days. The text of the revised note can be found at the EU online communication and information resource centre for administrations, businesses and citizens (Circabc). Read more

EU biocides industry criticises MRL Regulation

The last revision of the Regulation (EC) No 396/2005 on maximum residue levels of pesticides in,or on food and feed of plant and animal origin (MRLs Regulation) which concerns two quaternary ammonium compounds (Quats) - benzalkonium chloride (BAC) and didecyldimethylammonium chloride (DDAC) - in food products was published in the EU Official Journal on the 16th of October and entered into force on the 12th of November. This amendment of Annex III of the Regulation was met with scepticism by many biocides stakeholders, which called it ''inappropriate legislation'' due to its disruption of the EU biocidal products market.

The issue at stake relates to the interplay between the MRL Regulation, the Pesticides Directive 91/414/EEC which the MRL Regulation purports to amend (subsequently further repealed and replaced by Regulation 1107/2009), and the Biocidal Products Directive 98/8/EC (BPD) (as repealed and replaced by Biocidal Products Regulation 528/2012 (BPR).

In short, the MRL regulation is meant to apply to agricultural pesticides only, due to their link with the food chain; and indeed, according to Article 2(4) thereof, the MRL regulation applies without prejudice to the BPD/BPR. However, the confusion, and obviously the disappointment of the biocides industry, comes from Article 2(3) of the MRL Regulation, whereby the definition of "pesticide residue" includes residues "which may arise as a result of use in plant protection, in veterinary medicine and as a biocide". 

It is recalled that several years ago during a Competent Authorities' (CA) meeting, a Member
State voted on the inclusion of a biocide in Annex I, while another Member State raised the issue about residues in food in connection with this inclusion; however, both the Commission and the other CA's agreed at the time that this issue was not relevant for biocides, since the food chain falls under the separate pesticides Directive 91/414.

It seems that the debate is coming to the forefront again as a more general policy issue. Clearly, authorities will have to agree on how to evaluate and set MRL for biocides, while also considering instances when the evaluation of substances under the BPR might not be finalised, like the case with DDAC and BAC.


EU Commission releases guidance document of mixtures

The Joint Research Centre (JRC) of the European Commission has issued a report - Assessment of Mixtures, a review of regulatory requirements and guidance – which summarises the different methodologies used to assess the toxic effects of mixtures. It also provides an overview of current legislation in the EU and the extent to which this addresses their toxicological risk.

According to the document, some mixtures that need to be assessed are intentional and thus have a known composition, e.g. personal care products, food additives and pesticides. However, in many cases, mixtures are unintentional and (largely) of unknown composition, e.g. the combination of dozens to hundreds of substances in surface water, drinking water and air. It is namely the unintentional mixtures (contaminants, by-products and environmental pollutants) that are much more challenging to assess, because they are of varying and often complex composition, and many of the substances present are unidentified and toxicity data are lacking.

Legislation generally includes limit values for some of the known individual constituents.
Examples of EU legislation covering unintentional mixtures and their toxicological risk include: Regulations on contaminants in food (Regulation No 315/93/EEC and follow-up regulations); Regulation No 1935/2004 on food contact materials; water contaminants under the Water Framework Directive 2006/60/EC; Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work specifies maximum levels for individual substances, and it also refers explicitly to chemical agents in combination, covering both intentional and coincidental mixtures.

On the basis of this classification of mixtures (intentional vis-à-vis unintentional), scientists are recommending the use of two approaches to assess mixture toxicity: 1) testing of the whole product/mixture and 2) testing of the individual substances followed by mathematical modelling to predict the combined effect.

Although the guidance document acknowledges that the existing EU legislation protects humans and the environment against adverse effects of chemicals including mixtures, it nevertheless in many cases remains unclear how this is to be carried out and only few explicitly consider (real life) exposure to mixtures.

On-going Public Consultations

ECHA consults on seven testing proposals

ECHA is consulting on seven testing proposals on four substances. They are:

  • 3,5-diamino-4-[[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-2-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]benzoic acid sodium salt with testing proposed for genetic toxicity in vivo, based on concerns identified by the registrant;
  • Esterification products of 4,4'-isopropylidenediphenol, ethoxylated and prop-2-enoic acid with proposed testing for reproductive toxicity (prenatal development);
  • Reaction mass of 2,2'-[(4-methylphenyl)imino]bisethanol and Ethanol 2-[[2-(2-hydroxyethoxy)ethyl](4-methylphenyl)amino] with proposed testing for reproductive and genetic toxicity in vivo; and
  • Reaction products of hexane-1,6-diol with 2-(chloromethyl)oxirane with proposed testing for dermal and reproductive toxicity.

The deadline for all comments is the 2nd January 2015. A link to the testing proposals can be found here.

ECHA is holding a public consulation on 17 trichloroethylene authorisation applications

ECHA has launched consultations on 17 authorisation applications for uses of trichloroethylene (TCE).

These include:

  • As an extraction solvent for removal of process oil and formation of the porous structure in polyethylene based separators used in lead-acid batteries by Entek International;
  • As a processing aid in the biotransformation of starch to obtain betacyclodextrin by Roquette Frères; and
  • Industrial use as a process chemical in caprolactam purification by Grupa Azoty.

The deadline for comments on the applications is the 7th January 2015.

More details about the consultation can be found here.

RoHS stakeholder consultation

As part of the projects for the evaluation of applications for granting, renewing or revoking exemptions, to be included in or deleted from Annexes III and IV of the new RoHS Directive 2011/65/EU (RoHS 2), an online stakeholder consultation on an exemption request from the substance restrictions was opened on the 31st October and will run until the 9th January 2015.
In particular, the consultation covers two exemption requests for:

  • 2014-1 “Cadmium Anodes in Hersch cells for high-sensitivity oxygen sensors.”
  • 2014-2 “Lead in solders used to make electrical connections to temperature measurement sensors designed to be used periodically at temperature below -150C.”

The online enquiry is available here.

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