News about Environment and Toxicology

February 2012


New EU-wide biocides law from September 2013

The text of the Biocidal Products Regulation (BPR) is now in place after the EU Parliament and the Council have debated it for three years. In January and March 2012, the two bodies will vote the law into effect, and it will apply from 1 September 2013.

The most important features of the coming regulation include:

  • The function of treated articles will decide whether they are to be regarded as biocidal products or not
  • Families of biocidal products, ie biocidal products having similar uses, will be treated as one single product
  • Nanomaterials will be introduced as potential biocidal products and will be subjected to close scrutiny
  • New common EU-wide authorization for a large number of biocidal products
  • Certain biocidal products to be precluded from common EU authorization
  • EU authorizations to be granted from September 2013

DHI presumes that applications for approval of products on 1 September 2013 can be submitted to EU's chemicals authority ECHA about 1 April 2012.

For more details of the coming Biocidal Products Regulation, please click here.

Michael Fink
Tel +45 4516 9156

Watch out for chemicals of concern

Before a substance is identified as a Substance of Very High Concern (SVHC) or is proposed for harmonised Classification and Labelling in the EU, the substance is notified to the Registry of Intentions (ROI).

Notification of substances to ROI is submitted by EU member states authorities or the European Chemicals Agency (ECHA). Industry has the opportunity to come forward with information that should be considered before a final decision is made. Some intentions have been withdrawn after further evaluation.

Read more and view updated Registries of Intentions here.

Jens Tørsløv

Tel +45 4516 9022

First endocrine disruptor identified as SVHC

The substance 4-tert-octyl phenol is the first substance to be identified as a SVHC because of its endocrine disrupting properties causing probable serious effects to the environment. 4-tert-octyl phenol is mainly used in the manufacture of polymer preparations and of ethoxylate surfactants. It is further used as a component in adhesives, coatings, inks and rubber articles.

The substance was one of a total of 20 substances identified in late 2011 for the Candidate List of SVHC substances. For more details on the 20 substances, read here.

For more information on endocrine disruptors, contact
Gitte I. Petersen

Tel +45 4516 9312

GHS in the USA delayed

The office of Management and Budget (OMB) was set to review the GHS final rule and publish in the Code of Federal Regulations (CFR) by the end of January 2012. However, the OMB has extended the review.

The extension is for 30 days, so the final rule could be published by late February. It is also possible that the OMB will end up returning the final rule to the Occupational Safety and Health Administration (OSHA) for reconsideration and further review.

For more information on GHC and US chemicals legislation, please contact

Lars Skovgaard Rasmussen

+45 4516 9077

Safety data sheet guidance in 22 languages

The latest guidance from ECHA has just been published and concerns safety data sheets.

The Guidance on the compilation of safety data sheets is available in 22 official EU languages and describes good practice on how to fulfil your obligations. To download the guidance in English or any of the other 21 EU languages, click here.

For queries on safety data sheets, please contact

Helle M. Andersen
Tel: +45 4516 9023

Norway streamlines Working Environment Act

The Norwegian Labour Inspection Authority has decided to replace the current 47 regulations within health, environment and safety in the Working Environment Act with just six new regulations.

The aim is a simpler and more readily available legislation. The new regulations, which will not include significant content changes, will come into force on 1 January 2013.

For more information, please contact
Kirsten Møller

Tel +45 4516 9054

Life Science

Cosmetic Products Notification Portal now open

On 11 January the European Commission launched the Cosmetic Products Notification Portal (CPNP). The portal is described as a one stop shop for the cosmetic industry to submit information about the products, which they place on the EU market. The CPNP introduces a simple interface for submission of information on cosmetics. It is available in all EU official languages. To view the English CPNP User Manual, click here.

Compared with the current notification requirements, more detailed substance information is required for CPNP, however, taking confidential information into consideration.

The use of CPNP will be mandatory as of 11 July 2013, simultaneously with commencement of the last bit of the new cosmetics regulations. Please note, that the deadline is 11 January 2013 if the product contains nanomaterials.

Questions concerning cosmetics? Please ask
Lise Møller
Tel +45 4516 9133

Toxicity of nanoparticulate and ionic silver

DHI participates in the research project NanoTest, which aims to develop in vitro test models for safety assessment of nanoparticles. Studies include test of silver nanoparticles, which are one of the most frequently used nanomaterials in consumer products because of their antimicrobial properties.

In the most recent study, subacute toxicity of silver was investigated in rats. The rats were orally administered 14 nm nanoparticulate silver (Ag-NP) stabilised with polyvinylpyrrolidone and ionic silver in the form of silver acetate (Ag-acetate) for 28 days. Afterwards clinical, haematolological and biochemical parameters, organ weights, macro- and microscopic pathological changes were investigated. In addition, caecal bacterial phyla and their silver resistance genes were quantified.

Findings indicate toxicity of ionic silver
For the Ag-NP groups, no toxic effects were recorded. For Ag-acetate, lower body weight gain, increased plasma alkaline phosphatase, decreased plasma urea and lower absolute and relative thymus weight were recorded. In conclusion, these findings indicate toxicity of ionic silver but not of an equimolar dose of 14 nm Ag-NP. This is in accordance with previously reported data showing that oral Ag-acetate, in comparison with an equimolar dose of Ag-NP, resulted in higher silver plasma and organ concentrations. Data indicate that Ag-NP and Ag-acetate did not influence the microbiological balance in the gastrointestinal environment.

The study is described in the article Subacute oral toxicity investigation of nanoparticulate and ionic silver in rats, which has been published in Arch Toxicol. 2011 Oct 4.

The NanoTest project is financed by DHI and The Danish Food Industry Agency (DFFE). Researchers participate from The Technical University of Denmark, Copenhagen University, The University of Aarhus (Denmark), and The Chinese Academy of Sciences, China.

For more information, please contact co-author
Henrik Rye Lam


Synthetic milk alarm in India

A couple of years ago milk poisoning was fatal for Chinese toddlers. Now the Indian laboratory Equinox reports widespread adulteration of milk. In the city of Mumbai, Equinox believes that as much as 45% of the milk is likely to be adulterated.

Equinox has found traces of blotting paper, urea, ammonia, salt, sugar and several other contaminants in the milk. Blotting paper dissolves completely and adds thickness to milk diluted with water. Experts warn that adulterated milk can permanently damage vital organs when consumed regularly over a prolonged period of time. Furthermore, substances like urea and detergents, if ingested for a prolonged period even in small quantities, can lead to serious chronic disorders of the liver, kidneys and intestinal system. Read the full story on Equinox's website.

For questions about food contamination, please contact
Helle Buchardt Boyd

Tel +45 4516 9097

Food additive authorisations

In mid-January, EFSA concluded an open consultation on the draft guidance on the scientific data required for the safety evaluation of new food additives or new uses of authorised food additives. The coming guidance will combine data requirements as well as the applied risk assessment in a single document.

The document is arranged in four main sections, including a section on toxicological studies. For the toxicological studies, the draft guidance describes a tiered approach consisting of 3 tiers for which the testing requirements, key issues and triggers are comprehensively described.

Link to Draft Guidance for submission for food additive evaluations.

Helle Buchardt Boyd

Tel +45 4516 9097

Conference on microencapsulation of ingredients

Microencapsulation covers a broad range of topics as well as many scientific disciplines (chemistry, biology, physics and engineering, etc.). The market for microencapsulated active substances is growing quickly and Denmark - as a world leading food ingredients country - is very active in this domain.

On 7 March, the Innovative Ingredients initiative hosts a conference on Microencapsulation of Ingredients in Taastrup, Denmark. The seminar includes an international programme of speakers and is free of charge.

For more information and online registration, read here.

DHI is one of the partners of the the Innovative Ingredients initiative, which is coordinated by Biopeople.

Meet us at …

IMarEST Ballast Water Technology Conference, London
If you want to learn more about shipboard tests, please visit our stand at the above conference in London on 23-24 February 2012.

ChemCon Europe 2012, Madrid
Next year’s International Chemical Control Legislation conference will take place in Madrid from 5 - 9 March 2012. DHI is hosting a stand together with our business partners UMCO (Germany) and NCEC (UK).

24th DIA Annual EuroMeeting, Copenhagen
DHI also participates with a stand at the Annual EuroMeeting on 26-28 March in Copenhagen. The conference is hosted by DIA, the Drug Information Association - Europe.

Courses and seminars

Environmental Risk Assessment of Medicinal Products –17 April
Toxicology in one day –26 April

View all our courses in 2012 here.


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