At the end of November 2008 the EU finally approved the new regulation on classification, labelling and packaging of substances and mixtures. In the EU the regulation will be known as CLP (Classification, Labelling and Packaging). The regulation implements GHS, the Globally Harmonized System.

CLP will affect everybody who produce, sell or use chemicals. In practice all chemical substances and mixtures must be evaluated and classified according to new criteria. Hazard symbols (pictograms) and labelling phrases will be changed and so will safety data sheets.

Important deadlines
The final date for when CLP will come into force in the EU is not yet known. We expect that it will be at the beginning of 2009. After entry into force will follow a transitional period of approx. 7 years until all substances and mixtures have been classified and labelled according to the new regulation.

The first deadline is 1 December 2010 when all producers and dealers of substances must classify and label according to CLP. This applies to both new and existing substances. For mixtures the deadline is 1 June 2015. Substances and mixtures already on the market prior to the above deadlines need not be re-labelled until 2012 and 2017 respectively.

You may classify and label substances and mixtures as soon as the CLP regulation comes into force in 2009.

Be prepared
Although it is almost two years to the first deadline it is not a moment too soon to prepare yourself. First of all you must realize what role and consequently what obligations you have in CLP. Your IT systems must be able to handle classification according to CLP and safe data sheets and danger labels must also be adapted. Particularly, it will be a challenge to classify substances according to both the new and the old classification systems for a 5-year period.

Trading with non-EU countries
If you are trading with countries outside of the EU, you must be particularly watchful. Although GHS is introduced as a global system it is still possible to make local adaptations when GHS is implemented around the world. As a result, countries outside the EU might have other requirements than the EU. So be sure to keep up to date on how your trading partner countries implement GHS.

For more information on GHS and CLP read here.

Contact:

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

On 1 January 2009 new regulations on transport of dangerous goods are introduced.

The regulations comprise all forms of transport: air freight (IATA), by sea (IMDG), by road (ADR) and by rail (RID). Some of the rules will come into force immediately on 1 January 2009; for others there is a transitional period of up to a year.

There are significant changes for all transport areas. We outline a few of the important changes and give some advice on how to cope with the new rules.

Read more here.

Contact:

Lars Skovgaard Rasmussen
Email: lsr@dhigroup.com
Tel.: +45 4516 9077

The REACH regulation states the rules for safety data sheets (SDS) on chemical substances and mixtures. The SDS is mandatory for all classified substances and mixtures supplied to professional users. In addition an SDS must be available for professional users on request for unclassified products when they contain:

• 1% or more of a substance classified as hazardous to human health or the environment
• 1% or more of PBT or vPvB substances according to REACH
• a substance with an EU limit value

On 17 December 2008 the Danish Working Environment Authority has published a new executive order amending the Danish executive order on responsibilities for manufacturers, suppliers and importers of substances and materials. Besides the requirements from the REACH regulation, a safety data sheet must be available for professional users on request for unclassified substances and mixtures, which are included in the Danish list on limit values or which contain 1% or more of a substance on the said list. The executive order will come into force on 18 December 2008.

Contact:

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

Be familiar with chemicals in imported goods

According to the REACH regulation, consumers can demand information on substances of very high concern (SVHC substances) in consumer products. In REACH many consumer products fall under the definition articles. Articles include both large consumer products such as cars, furniture, refrigerators, bicycles, clothes/textiles, and handbags, but also small items such as toothbrushes, pencils, and mobile/cell phones.

The regulation applies to goods/articles which are produced in or imported into the EU.

The EU List of Substances of Very High Concern
The SVHC substances are listed on the EU Candidate List of Substances of Very High Concern published by ECHA (European Chemicals Agency). The list includes common plastic softeners such as dibutyl phthalate and DEHP.

If for instance a consumer wants to know if a pair of wellingtons contains DEHP, the shop must provide sufficient information to the consumer within 45 days of the request (if the substance concentration is above 0.1% (w/w)). It does not matter whether the goods are bought in a shop or via the internet.

You should pay particular attention to this requirement if you produce or import

• Toys (teddy bears, balls, equipment for roleplaying, etc.)
• Electrical goods and appliances

Even though you fulfil the ROHS* conditions concerning electrical goods and appliances or the EU directive on phthalates concerning toys, you must also comply with the REACH requirements.

See EU’s list of Substances of Very High Concern (REACH, annex 1) here.

*ROHS = Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment

Contact:

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

Charlotte Præst
Email: chp@dhigroup.com
Tel.: +45 4516 9074

Do you need help to decide which laboratory tests are relevant when information on physico-chemical, toxicological or ecotoxicological properties of your chemicals are needed to meet the requirements under REACH?

Do you need information on which tests and test organisms are relevant to make an environmental risk assessment for a pharmaceutical product as required by the EMEA (European Medicine Agency) guideline?

A new DHI website has been launched which provides the answers. This site also provides information on relevant tests when PBT (Persistence, Bioaccumulation, Toxicity) should be determined for substances for which a chemical safety assessment must be conducted.

Read more here: http://lab.dhigroup.com

Contact:

Louise Schlüter
Email: lsc@dhigroup.com
Tel.: +45 4516 9557

Antiseptics and disinfectants are widely used in the home, in the food and feed industries, and in hospitals. Those biocides are supposed to keep harmful bacteria and other microorganisms at bay.

The European Union’s Biocidal Products Directive emphasizes one particular hazard for biocides: that the development of resistance towards a biocide might also be resis­tance to an antibiotic. For instance, it is known that the widely used biocide triclosan can endanger antibiotic treatment of tuberculosis and staph skin infections.

From January 2009 DHI is part of a 4-year international research project that aims at understanding and predicting simultaneous resistance to antibiotics and biocides. For more information read here.

Contact:

Stephen Wessels
Email: sww@dhigroup.com
Tel.: +45 4516 9162

In October 2008 the Danish Veterinary and Food Administration (DVFA) submitted a proposal for regulation of additions to food concerning ingredients with nutritional or physiological effects.

The Danish regulation will affect all articles of food, including food supplements, and is expected to come into force in mid-2009. If an ingredient with nutritional or physiological effects is not listed on annex 1 of the new regulation, then producers and importers must wait for up to 6 months for a decision from the  DVFA whether the ingredient can be accepted or not.

DHI can assist you if you need safety assessments of ingredients with nutritional or physiological effects that are not included in annex 1, or if you wish to use an ingredient in concentrations higher than the listed concentrations.

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

Soda fountains and similar drink dispensers that are found in fast food restaurants, cafes and the like, have suddenly become the focus of interest in the Danish news. It is suspected that the soda fountains liberate substances that may be harmful to human health. Moreover, it has turned out that many proprietors do not know that in Denmark the soda fountains require an official approval.

This approval is popularly known as a VA approval. But what exactly is a VA approval and how do you obtain it? Read more here.

Contact:

Hanne Sørensen
Email: hso@dhigroup.com
Tel.: +45 4516 9159

China is presently experiencing one of the largest contamination food scandals. The contamination has resulted in death and severe kidney injuries in many small children.

The EU migration limit for melamine from food contact materials is 30 mg/kg food, whereas the EU regulation in connection with import is 2.5 mg/kg from all sources including migration. This discrepancy might be due to the fact that the melamine used for food fraud is not pure and that direct addition of melamine to food is not acceptable under any circumstances.

Long-term contamination
An interesting theory was recently put forward that the spiking with melamine might have been going on for quite a while. The fact that adverse effects have started to show may be due to altered melamine manufacturing processes which produce impurities. One such impurity is cyanuric acid.

Together with melamine, cyanuric acid may form insoluble complexes. If both substances are found in the urine they can precipitate and clog up the kidneys resulting in kidney injuries. The risk of forming insoluble complexes increases with the amount of cyanuric acid in the melamine. Consequently, it is not possible to estimate the health risk of a melamine contamination if the content of cyanuric acid is not known.

TDI for melamine
The World Health Organization (WHO) has just recently established a tolerable daily intake (TDI) for melamine at 0.2 mg/kg body weight. This is lower than some TDIs previously suggested by some national food safety authorities. The TDI applies to melamine alone. The TDI for cyanuric acid alone remains at 1.5 mg/kg body weight. WHO remarks that co-occurrence of melamine with cyanuric acid seems to be more toxic, but they find that adequate data are not available to allow the calculation of a health-based guidance value for this co-exposure.

Source: http://www.who.int/mediacentre/news/releases/2008/pr48/en/index.html

Contact:

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

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Centre for Environment and Toxicology

Agern Allé 5
2970 Hørsholm
Denmark

Tel: +45 4516 9200.
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