News about Environment and Toxicology June 2008

After REACH comes GHS

Today, just one year into the REACH process, the EU expects to adopt GHS (the Globally Harmonized System of classification and labelling) during 2008. However, as you can read below, the worldwide implementation of GHS is making slow progress.

As a follow-up on our story on the biocidal products directive in May, in this issue we try to clarify the definition of a biocidal product; a term which is the cause of some confusion.

You may also find it interesting to learn about a new Danish research project which aims to break down bacterial disease pathways and reduce infections in the Danish poultry production.

Enjoy your summer holidays.



Chemicals ^
Implementation of GHS is making slow progress ^

Kun få lande har implementeret GHS

When GHS (the Globally Harmonized System of classification and labelling) was adopted in 2002, countries worldwide were encouraged to implement GHS as soon as possible and to have the system fully operational by 2008. It has, however, not worked out that way. So far only New Zealand and Japan have implemented GHS, and Korea and the EU are expected to introduce GHS during 2008.

In New Zealand you are allowed to label chemical products according to label requirements in the EU, Australia, USA or Canada until 31 December 2010, but safety data sheets must be prepared according to GHS from 1 July 2008.

Transitional period in the EU and Korea
In the EU and Korea a transitional period is expected for reclassification of substances and mixtures until 2010 and 2015 respectively after which GHS will replace the existing regulation.

The GHS versions in the EU and in Korea are similar to one another, but differ from the UN version of GHS by not having implemented all categories. In addition, the EU and Korea versions contain parts of the present legislation which is not covered by the UN version. This is also expected to happen in many of the countries which have not yet implemented GHS.

In the rest of the world the implementation of GHS varies a great deal. Some countries are in the process of implementing GHS, whereas other countries await developments. This is due to the fact that GHS differs considerably from existing classification and labelling systems. The countries must consider their present legislation and which parts of the GHS legislation they wish to implement.

In the long term a globally harmonized system is expected, however, don’t expect it to be just round the corner. Consequently, companies must still comply with different regulations when exporting, importing, and/or using chemical products.

Update of substance lists (inventories)
Furthermore, many countries are in the process of updating national substance lists (inventories) such as lists of dangerous substances. Be aware that the classifications on various substance lists may differ from the harmonized classifications known in the EU.

For more information on GHS, please contact Henriette Christiansen.

DHI is holding a course on GHS on 18 November 2008. For more information, read here.

Contact:

Henriette Christiansen
Email: hc@dhigroup.com
Tel.: +45 4516 9030



When are chemical products also biocidal products? ^

Chemical products against growth of algae as well as wood preservatives, rat poisons, insect repellents, etc. are all biocidal products. In line with the implementation of EU’s Biocidal Products Directive in the membership countries the focus on notification and approval of biocidal active substances has increased. It is, however, also important to focus on chemical products which contain biocidal active substances together with other chemical substances.

It can be difficult to determine when a chemical product also fulfils the definition of a biocidal product. A product that contains a biocidal active substance, e.g. a preservative, is not necessarily covered by the regulation on biocidal products although one might think so.

Two conditions
A product is covered by the regulation on biocidal products if it meets the following two conditions:

  1. the product contains one or more biocidal active substances
  2. the product is marketed with the purpose of hampering or killing unwanted organisms (e.g. to prevent growth of algae, to have a disinfecting effect, a preservative or an insect repellent)

Chemical products, which meet both conditions, are called biocidal products. Pay attention especially to the second condition.

If a substance has been added to a product solely to improve the durability of the product, and the product does not have a preservative or disinfecting effect (e.g. a cleansing agent, a lubricant or paint) then the product is not a biocidal product and as a result it is not covered by the biocidal regulation.

If the product is to be covered by the regulation on biocidal products it must meet some requirements. For one thing the biocidal active substance must be approved for the use in question; for another the biocidal product must be approved by the authorities in the country of marketing.

23 product types in the EU
In the EU 23 different product types have been defined. All biocidal products belong to one of these product types which has been defined based on the use of the product. When the EU Biocidal Products Directive has been fully implemented in all member states, biocidal products for all 23 product types must be approved. Until then the approval requirements vary from country to country.

As for any other chemical product a biocidal product must fulfil the requirement concerning classification, hazard labelling, and safety data sheets. The biocidal product may also be covered by the rules concerning product registration. In addition, there are supplementary rules concerning labelling of biocidal products.

Contact:

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



New REACH website ^

In connection with the commencement of pre-registration of chemical substances under REACH on 1 June 2008, DHI launched a new REACH website.

At the website we present our services in REACH. The pre-registration is the first of many more obligations: formation of Substance Information Exchange Fora (SIEF), data evaluations, testing strategies, and chemical safety assessments among others.

Many downstream users of substances worry about REACH and the possible consequences for their production. Some of the issues are:

  • What if my supplier does not pre-register the key substance of my production?
  • Would it be possible to proceed with a specific use of a substance not supported by my supplier?

Take a look at the REACH website here.

Contact:

Margrethe Winther-Nielsen
Email: mwn@dhigroup.com
Tel.: +45 4516 9320



And the winner is ... ^

Thanks to everybody who visited our stand at the REACH Corner of Chemspec Europe 2008 in Munich in June.

The winner of our competition is Dr David Karsa of TensioMetrics Ltd., Great Britain. The prize is on the way.

Contact:

Peter Kortegaard
Email: pko@dhigroup.com
Tel.: +45 4516 9049



Food ^
Poultry project to break down bacterial disease ^

Nyt fjerkræprojekt vil bryde  bakteriers smitteveje

Infections cost money, especially in poultry productions because of the large flock sizes. Annually, Danish poultry producers lose 10-15% of their production value due to bacterial infections and less optimal hygienic conditions in the poultry stables. Consequently, there is an obvious need to strengthen product safety and animal welfare in the Danish poultry production.

DHI is in charge of an innovation consortium which aims to break down bacterial disease pathways and reduce infections in the Danish poultry production.

For more information read here.

Danish readers may also want to visit the CHIP homepage

Contact:

Anders Permin
Email: ape@dhigroup.com
Tel.: +45 4516 9173



Aflatoxin limits in nuts may be laxed ^

Grænseværdi  for aflatoksiner kan lempes

Changing the maximum levels for aflatoxins from 4 to 8 or 10 µg/kg in almonds, hazelnuts and pistachios would only have minor effects on dietary exposure and cancer risk. This is the conclusion reached by EFSA.

The Europan Food Safety Authority (EFSA) has considered approx. 40,000 analytical results in various food commodities for its review of aflatoxin limits in almonds, hazelnuts and pistachios and derived products. The EU introduced limits on aflatoxins in 1998 because they are considered to be genotoxic and carcinogenic. The current EU maximum level is 4 µg/kg for total aflatoxins. However, recently Codex Alimentarius has proposed to increase this limit to 8 or 10 µg/kg worldwide.

Based on the analytical results EFSA’s scientific panel on contaminants in the food chain concluded that changing the maximum levels for total aflatoxins from 4 to 8 or 10 µg/kg in almonds, hazelnuts and pistachios would have minor effects on the estimates of dietary exposure and cancer risk.

Aflatoxins are produced by moulds that are especially found in areas with hot, humid climates. They are most likely to contaminate tree nuts, ground nuts, figs and other dried fruits, spices, etc.

For more details on EFSA’s opinion on Aflatoxin limits in nuts please refer to EFSA’s homepage.

Contact:

Birgitte Reimers
Email: rei@dhigroup.com
Tel.: +45 4516 9422



Discount on research to Danish companies ^
^

The Advisory and Funding System for Research and Innovation in Denmark has launched a new discount system in which they offer small and medium-sized companies coupons for purchase of knowledge and research.

Companies in Denmark may use the coupons when they seek new knowledge, or the coupons may be used to encourage corporation between companies and public institutions in research and knowledge.

A total of 70 mill. Danish kroner have been allocated to the coupons in 2008 and 2009. Danish readers, who want to know more about the scheme, can find more information here.

Contact:

Karen Edelvang
Email: kae@dhigroup.com
Tel.: +45 4516 9117



Coming courses ^



Contact ^

DHI
Centre for Environment and Toxicology

Agern Allé 5
2970 Hørsholm
Denmark

Tel: +45 4516 9200.
Fax: +45 4516 9292

www.dhigroup.com

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