News about Environment and Toxicology

June 2014


Chemicals

Next CLP deadline approaching

First deadline is 1 December 2014
The fourth and fifth adaptation to the CLP Regulation will soon become effective. The first deadline is 1 December 2014.

The fourth adaptation features some amendments concerning the criteria for classification and labelling, for instance new rules on classification of aerosols and new labelling of inner packaging below 10 ml. The new rules will apply from 1 December 2014 (substances) and 1 June 2015 (mixtures), respectively.

The fifth adaptation includes amendments to Annex VI of the CLP Regulation (harmonised classification and labelling). Especially the amendment of the classification for white spirit (CAS# 8052-41-3) is interesting. Until now, white spirit has had a more severe classification in Denmark than in the other EU member states due to separate Danish regulation. However, as of 1 December 2014 all EU countries must classify white spirit according to the present Danish classification.

The sixth adaptation also includes amendments to Annex VI. The classifications for styrene and formaldehyde will be tightened up, among other things. The new and amended classifications must be applied by 1 April 2015.

Transitional period expires
So far chemical mixtures have been covered by a transitional scheme and suppliers have been free to classify either according to the old rules or according to the CLP Regulation. The end of this transition period is drawing close. As from 1 July 2015 all chemical mixtures must be classified in agreement with the CLP Regulation. It is still permitted to "translate" old classifications of mixtures already on the market. For more guidance, check ECHA's website on CLP 2015.

For more information on CLP, you are also welcome to contact

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

Additional physical–chemical data for the simplified biocide authorisation procedure

Storage conditions and product shelf-life may adversely affect active substances and thus the efficacy of biocidal products. In May 2014 the European Commission has issued a Note for Guidance, which concludes that data on storage stability and shelf-life shall also be included in applications for product authorisation submitted through the simplified authorisation procedure. In addition to the present requirements for efficacy data, this will entail more data on a product's physical-chemical properties.

The Commission suggests that the requirement is adapted on a case by case basis provided that sufficient data is submitted that demonstrates product stability and proposed shelf-life.

For more information, read here.

Have a question concerning biocidal products? Please contact

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

Danish register on nanoproducts

On 18 June 2014, the Danish Ministry of the Environment issued an executive order on registration of nanoproducts. As of this date Danish companies manufacturing or importing consumer goods containing nanomaterials on the Danish market are obliged to register products in the national nanoproduct register.

The purpose of the register is to generate an overview of consumer products containing nanomaterials on the Danish market. The register is part of a larger initiative to establish the impact of nanomaterials on human health and the environment.

Together with the registration data requirements, the executive order lists exemptions for registration with regard to product categories, products and nanomaterials. Only consumer products or articles with a potential release of nanomaterials are to be registered. A guidance (in Danish) on how to cope with the registration obligations has been published by the Danish EPA.

First registration deadline
The first registration deadline is 30 August 2015. By this date, products must be registered for the period from 20 June 2014 until 20 June 2015.

So far the Ministry of the Environment has only published a press release about the new executive order in Danish.

For more information on nanomaterials and nanoregistration, please contact

Poul Bo Larsen
pbl@dhigroup.com
Tel +45 4516 9478

Trichloroethylene evaluated as non-threshold carcinogen

As part of the ongoing work of establishing dose-response relationships or DNELs* for substances on ECHA's Authorisation List, DHI has evaluated the carcinogenicity of trichloroethylene.

DHI provided a review of the carcinogenic dose-response relationship of trichloroethylene focusing on a series of expert assessments conducted since 2000. Supported by these expert evaluations, it is concluded that due to the genotoxic potential trichloroethylene should be evaluated as a non-threshold carcinogen. The dose-response was based on the increased risk of kidney cancer which has been observed in several epidemiological studies.

Trichloroethylene is used in cleaning agents, e.g. for degreasing in the metal-working industry.

The work was initiated by ECHA's Committee for Risk Assessment (RAC) and is published on the ECHA website: Application for Authorisation: Establishing a Reference Dose Response Relationship for Carcinogenicity of Trichloroethylene.

For more information, please contact

Poul Bo Larsen
pbl@dhigroup.com
Tel +45 4516 9478

*DNELs: Derived No Effect Level


Life science & cosmetics

Danish requirement for registration of medical devices

Manufacturers of medical devices, which export to the Danish market and are represented by an authorised representative, should be aware of new legal registration requirements. As from 1 June 2014 all authorised representatives of medical devices in Denmark must be registered via the Danish Health and Medicines Authority. This also includes authorised representatives of manufacturers outside the EU.

Until now the requirement has included class I medical devices. From 1 June the requirement also includes other devices, including class IIa, IIb and III.

For more information, please contact your representative or our medical device specialist

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

Denmark loosens regulation on propylparaben and butylparaben in cosmetics

Since 2011 propylparaben and butylparaben have been covered by a temporary total ban in cosmetic products in Denmark. In February 2014 the EU adopted a new regulation, which restricts the use of propylparaben and butylparaben. Consequently, Denmark must revoke its temporary national ban. For instance the parabens may now be used in suntan lotions to children under three years. Both parabens have been assessed safe for use in a total concentration of 0.14% in all types of products, with the exception of non-rinse off products such as wet wipes or lotions used in the nappy area of children under three years.

Five parabens banned in the EU
In 2011 Denmark issued a national ban on the use of propylparaben, isopropylparaben, butylparaben and isobutylparaben in all products to children under three years. Since then isopropylparaben and isobutylparaben have been banned in the EU in all cosmetic products for both children and adults. In the autumn of 2013, the use of isopropylparaben, isobutylparaben, phenylparaben, benzylparaben and pentylparabens was banned in the EU. The ban has a transitional period of 15 months so the substances can still be found in products on the market until around February 2015.

Methylparaben and ethylparaben are safe to use
Neither methylparaben nor ethylparaben are covered by any bans in the EU. The EU Scientific Committee for Consumer Safety has assessed that these two parabens do not constitute a health risk in cosmetics in the concentrations used.

Why add parabens?
Parabens are preservatives used to prevent growth of fungus or bacteria in products such as cosmetics, medicinal products or food. As opposed to many other preservatives, parabens rarely cause allergy.

Contact
Lise Møller
lmm@dhigroup.com
Tel +45 4516 9133


Food

Adverse effects from dietary supplements containing bitter orange substance

P-synephrine is a substance found in the skin of bitter oranges. The substance is also used as an ingredient in numerous so-called "weight-loss" food supplements. In an assessment from May 2014, the French Agency for Food, ANSES, recommends that intake levels of p-synephrine through food supplements must remain below 20 mg/day.

Further, ANSES recommends not taking p-synephrine with caffeine or during physical exercise.
The recommendation is based on an assessment by ANSES of several reports of adverse effects likely to be linked to food supplements containing p-synephrine. Adverse effects include cardiovascular effects, liver damage, hyperphosphoremia and neurological damage.

During the assessment, ANSES established that many of the food supplements currently on the market provide a daily intake of p-synephrine which surpasses the above reference value.

For questions on dietary supplements, please contact

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

Help EFSA improve statistical reporting

The European Food Safety Authority, EFSA, has launched an open consultation on its Draft Guidance on Statistical Reporting.

The purpose is to improve the reporting of statistics in a harmonised and standardised way. Many and varied sources are required to carry out risk assessments. Further, lack of relevant information may delay the process. As a result, improved statistical reporting will benefit both EFSA and its stakeholders.

Comments to the open consultation must be submitted by an electronic template. Deadline for written comments is 23 July 2014.

For more information, please read here.

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


Meet us

Euroscience Open Forum - Denmark
DHI has an exhibition stand at ESOF 2014 in Copenhagen, Denmark, on 21-26 June. An important element of ESOF 2014 is a public outreach programme - the Science in the City Festival. The festival's goal is to build bridges between researchers, delegates and the general public using interactive exhibits.

Eurotox Edinburgh 2014
Helle Buchardt Boyd and Poul Bo Larsen will attend the 50th Congress of the European Societies of Toxicology in Edinburgh, Scotland from 7-10 September 2014.

ICAB 2014 - Denmark
Louise Schlüter will participate in the 2nd International Conference on Algal Biorefinery: A potential source of food, feed, biochemicals, biofuels and biofertilizers. Louise presents a poster on algal cultivation at the conference, which takes place on 27-29 August 2014 in Denmark.

BWMTech North America - USA
Gitte Pedersen and Torben Madsen participate in the Ballast Water Management Technology Conference North America on 25-26 September 2014 in Miami, USA. Gitte is also one of the speakers at the conference.

Courses – autumn 2014

GHS single substance course - 25 August, Singapore

GHS Mixture course - 9 + 10 September, Singapore

Applied Toxicology - 24 + 25 September, Denmark

QSAR workshop - 8 October, Denmark

Environmental Hazard Assessment, A general introduction - 13 October, The Philippines

GHS - Classification and labelling of chemicals - 14 October, The Philippines

IUCLID 5: Training for REACH and Biocide Registration Dossiers - 19 + 20 November, Denmark

For Danish courses in Environment and Toxicology, please see here.

GHS conference in Singapore a success
On 5-6 May Singapore Chemical Industry Council (SCIC) organised a GHS conference. The event consisted of a one-day workshop on different aspects of GHS hosted by DHI followed by a one day conference with various speakers, including DHI. The main interest from industry was the updated GHS standard SS 586 2014, which adopts the 4th version of UN GHS and introduces new building blocks, obtaining and validating information from suppliers and how to deal with workplace labelling. More than 100 people participated in the conference. Coming up next is the GHS deadline of 2015, where all mixtures must be classified and labelled according to GHS, including workplace chemicals.

For more information on GHS, workplace labelling and training in Singapore, please contact
Henriette Christiansen
hc@dhigroup.com

Contact

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



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