News about Environment and Toxicology

Dec 2013


Chemicals

Impending ban on triclosan

This December the EU Biocides Competent Authorities will discuss the non-approval of nine active substances under the EU Biocidal Products Regulation. This arises because all participants in the review of these substances have discontinued their participation in the review programme, or no complete dossier was received within the specified time period. Non-approval means that the active substances and the biocidal products containing them for the specified uses must be removed from the EU market.

One of the substances up for discussion is triclosan and its use in the product types 2, 7 and 9. Type 2 includes the use of triclosan for disinfection of surfaces in the public health sector.

Final decision on non-approval is expected to be taken by mid-March 2014. Triclosan is still under evaluation in product-type 1: biocidal products used for human hygiene purposes, applied on or in contact with human skin.

For more information, please contact

Dorthe Nørgaard Andersen
dna@dhigroup.com
Tel +45 4516 9088

Updated Guidance on application of CLP Criteria

ECHA has published an update to the Guidance on the Application of the CLP Criteria. The update was required due to the adaptations in April 2011 and June 2013, respectively. Updates have been made in the following parts:

  • Part 2: Physical hazards
  • Part 3: Health hazards

Furthermore, corrigenda have been made of

  • Part 1: General principles for classification and labelling
  • Part 4: Environmental hazards and its related Annexes I-V

Click here to view the full Guidance on the Application of the CLP Criteria (pdf, 663 page).

For further questions on CLP, classification and labelling, please contact

Helle M. Andersen
hma@dhigroup.com
Tel +45 4516 9023

ECHA launches first public consultation on biocidal active substance

The active substance dinotefuran is the first biocidal substance to be launched by ECHA as a potential candidate for substitution.

Dinotefuran is proposed to be used in biocidal products of product-type 18 (insecticides, acaricides and products to control other arthropods). When an active substance is a candidate for substitution, biocidal products containing the active substance will become subject to a comparative assessment at the time of authorisation and will only be authorised if there are no better alternatives.

The consultation is open until 28 January 2014. After this date, ECHA will evaluate the information received and finalise the opinion on dinotefuran.

For more information, please contact

Michael Fink
mif@dhigroup.com
Tel +45 4516 9156

Seven biocidal actives scheduled for approval

The EU has notified that seven existing active substances are scheduled for approval for use in specified biocidal product types under the EU Biocidal Products Regulation. The notifications comprise the following substances:

  • cyproconazole (product type 8)
  • amorphous silicon dioxide (product type 18)
  • ethyl butylacetylaminopropionate (product type 19)
  • copper pyrithione (product type 21)
  • 4,5-dichloro-2-octyl-2H-isothiazol-3-one (product type 21)
  • transfluthrin (product type 18)
  • lauric acid (product type 19)

The proposed dates of adoption are planned for January 2014.

For more information on biocidal products and biocidal regulation, please contact

Michael Fink
mif@dhigroup.com
Tel +45 4516 9156

Life science

Polyfluorinated substances cause growing concern

Organic polyfluorinated substances are used widely in many ordinary consumer goods. Despite the common use we lack important knowledge on their chemical composition, the amounts produced and how widely the substances are used.

This causes concern with scientists. Research increasingly indicates that the fluorinated substances may harm both the environment and human health, e.g. by being carcinogenic.

Polyfluorinated substances substitute other polyfluorinated substances
Furthermore, known toxic polyfluorinated substances are substituted by other polyfluorinated substances with similar properties. Consequently, more scientific data and improved methods of analysis are required to predict possible harmful effects of the various polyfluorinated substances.

In a large Nordic study, researchers have mapped the use of fluorinated substances in The Nordic countries and deduced that further regulation is required concerning their use in consumer products.

You can view the full report Per- and polyfluorinated substances in the Nordic Countries. Use, occurrence and toxicology here (pdf, 230 pages).

For more information on fluorinated substances, please also contact

Helle Buchardt Boyd
hbb@dhigroup.com
Tel +45 4516 9097

New centre for welfare of test animals

The Danish Ministry of Food, Agriculture and Fisheries has formed a new 3R-centre to ensure the welfare of test animals. The three Rs stand for Replacement, Reduction and Refinement. The centre will strive to use non-animal test methods (replacement), develop methods to reduce the number of animals used (reduction) and methods which will improve animal welfare (refinement). The centre will collaborate with similar centres worldwide, including exchange of knowledge and information.

The Danish centre is co-financed by animal protection organisations, the pharmaceutical industry and the Ministry of Food, Agriculture and Fisheries.

Ann Detmer
ad@dhigroup.com

Food

Reduced limit values for lead and cadmium in metallic food contact materials

The Council of Europe has published a new technical guide on Metals and alloys used in food contact materials and articles. The recommended limit values for lead and cadmium are based on the latest evaluations by EFSA and are as follows:

  • 0.005 mg cadmium/kg food
  • 0.010 mg lead/kg food

As all EU membership states have participated in preparing the resolution, a future EU regulation is anticipated. So far a public hearing has been conducted concerning a lowering of the migration limit value for lead and cadmium from ceramic products, i.e. a reduction by 60 times for cadmium and 400 times for lead.

Use citric acid for migration testing
Although the resolution of the Council of Europe is not legally binding, we recommend referring to the new resolution when preparing declarations of conformity for metallic food contact materials. Many of the former national rules and regulations must be considered obsolete. The guide also gives new methods for migration testing, for instance the recommendation to use citric acid as a simulant instead of acetic acid.

For further questions, please contact

Helle Buchardt Boyd
hbb@dhigroup.com
Tel +45 4516 9097


Meet us

8th International Fresenius Conference, Germany
Michael Fink has been invited to speak about How to deal with the Biocidal Products Regulation – requirements for formulators and professional users of disinfectants, at the Fresenius Conference on Detergents and Cleaning Products on 12 and 13 February 2014 in Mainz, Germany

ChemCon Europe 2014, Turkey
DHI participates at the International Conference on Chemical Control Legislation & Trade Aspects (ChemCon) which takes place on 31 March thru 4 April 2014 in Istanbul, Turkey.

Contact

DHI | Agern Allé 5 | 2970 Hørsholm | Denmark
Tel: +45 4516 9200 | Fax: +45 4516 9292 | www.tox.dhigroup.com



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