The new EU classification and labelling system, named CLP, came into force on 20 January 2009 and is effective in all membership countries. CLP implements the globally harmonized system, GHS. You can already now classify and label chemical substances and mixtures according to the CLP regulation although it is not mandatory until 1 December 2010 (substances) and 1 June 2015 (mixtures).

New rules give rise to many questions
The new classification rules raise quite a lot of questions. Particularly concerning calculation of classifications for mixtures as a number of details are not described in the regulation. For the present ECHA, the European Chemicals Agency, is working on guidelines for the new rules. These are expected to be completed during the summer 2009.

Annex I to the Dangerous Substance Directive (67/548/EEC) is now part of the CLP regulation. It is included in Annex VI, part 3, and called the Harmonised List of Hazardous Substances. As a result Annex I to the Dangerous Substance Directive will no longer be updated and any adaptations will be added to the CLP regulation at the next update in June 2009. On 1 June 2015 the Dangerous Substance Directive will be repealed altogether.

M factor
It is important to observe that you cannot merely use a classification from the harmonised list. It is a requirement that producers and importers of substances assess whether the substances should be classified for other hazards than those mentioned. At the same time, substance producers and importers must determine an M factor (multiplication factor) for all environmentally hazardous substances unless an M factor is already listed in the harmonised list.

Contact:

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

DHI holds a one-day course in GHS and CLP on 12 May.

The CLP regulation was published in the EU Official Journal on 31 December 2008 and is available in all official EU languages. As a regulation it is effective in all EU countries, however, non-EU members such as Norway must implement the regulation as national law.

In Norway it is the Ministry of Foreign Affairs which is responsible for translation of the EU regulation. It is expected that a provisional translation will be ready this month (March 2009) and the final version in April. The Norwegian Pollution Control Authority, which is responsible for the CLP regulation in Norway, will then submit the statutory order for consultation during the summer.

When the regulation has been passed it will replace the former Norwegian regulation on classification and labelling, which is based on the EU dangerous substance and dangerous preparations directives.

Contact:

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

In our December 2008 issue we stressed the importance of being familiar with chemicals in imported goods, especially chemicals known as Substances of Very High Concern (SVHC substances).

In February 2009, ECHA (the European Chemicals Agency) announced new deadlines for these substances.

Since 28 October 2008 EU suppliers of articles which contain substances on the SVHC Candidate List in a concentration above 0.1% (w/w) must provide information to their customers and on request to a consumer within 45 days of the receipt of this request.

New deadlines for notification
From 2011, EU producers or importers of articles will have to notify ECHA if their article contains a substance on the Candidate List. This obligation applies if the substance is above 0.1% (w/w) and its quantities in the produced/imported articles are above 1 tonne in total per year per company. REACH requires that for substances included in the Candidate List before 1 December 2010, the notifications have to be submitted not later than 1 June 2011, and for substances included in the Candidate List on or after 1 December 2010, the notifications have to be submitted no later than 6 months after the date of inclusion.

Contact:

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

In September 2008 the Swedish government introduced a ban on retail sales of laundry detergents containing phosphates. Now they want to follow up with a ban on phosphates in dishwasher detergents for private use from 1 July 2011. The ban means that it will not be permitted to manufacture or market dishwasher detergents with a phosphorus content of more than 0.5 per cent by weight. A ban on phosphates in dishwasher detergents will mean a further reduction in phosphorus emissions of 20 tonnes per year.

The government's decision is part of the commitment made by Sweden and the other Baltic countries in the Baltic Sea Action Plan. These countries are to replace phosphates in laundry detergents and look into the possibility of replacing phosphates in dishwasher detergents.

For more information read here.

Contact:

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

Every second year Danish companies must report sales amount to the Product Register of registered products.

If DHI has notified products for your company with the Product Register you will receive a list of all your notified products directly from the Product Register. You must return this list to the Product Register by 1 April 2009 with a report on sales in 2008.

If you have not received a list, you should contact the Product Register: pd@at.dk

Contact:

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

A new regulation on advanced therapy medicinal products came into force on 30 December 2008. The Regulation on advanced therapy medicinal products specifically governs gene therapy medicinal products, somatic cell therapy medicinal products and tissue engineered products.

The Regulation supplements the general provisions of EU law governing medicinal products for human use and introduces specific rules for tissue engineered products. The requirements for gene therapy medicinal products and somatic cell therapy are only affected by the Regulation to a minor degree.

Tissue engineered products
The regulation defines a tissue engineered product as a product that contains or consists of engineered cells or tissues, and is presented as having properties for, or is used in or administered to human beings with a view to regenerating, repairing or replacing a human tissue.  A tissue engineered product may contain cells or tissues of human or animal origin, or both. The cells or tissues may be viable or non-viable.

Read more about Regulation (EC) No 1394/2007 on advanced therapy medicinal products here.

Contact:

Ann Detmer
Email: ad@dhigroup.com
Tel.: +45 4516 9103

Print on a cardboard packaging can migrate to the food even though the product is protected by extra packaging inside the cardboard box. This is concluded after high concentrations of the toxic substance 4-methylbenzophenone has been found in müsli produced in Belgium.

The müsli was marketed in packaging produced in Holland and was distributed in the Danish Lidl supermarkets under the name of Bellona. The substance 4-methylbenzophenone is used in print ink which is used to decorate cardboard boxes. 4-methylbenzophenone may migrate if the print is not allowed to cure for sufficient time. This can be the result of implementing LEAN or other product effective measures.

At DHI we assess print ink, packaging and production conditions in order to minimize the migration of substances to the food.

Contact:

Eva Høy Engelund
Email: ehe@dhigroup.com
Tel.: +45 4516 9200

Four new EU regulations on food additives; on food enzymes; on flavourings and certain food ingredients with flavouring properties for use in and on foods; and on a common authorisation procedure for food additives, food enzymes and food flavourings came into force on 20 January 2009.

We encourage our readers to familiarize themselves with the new regulations. We would, however, alert you to the fact that as from 20 July 2010 food containing a number of specified food colours must be labelled as follows: “May have an adverse effect on activity and attention in children”.

The food colours in question are: Sunset Yellow (E110), Quinoline Yellow (E 104), Carmoisine (E122), Allura Red (E 129), Tartrazine (E 102) and Ponceau 4R (E124).

Contact DHI for further information, if you need assistance with approval and re-evaluation of food additives, food flavourings, or food enzymes.

Contact:

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

Worldwide the Food Safety Authorities have defined rules for compulsory labelling of major food allergens. This is particularly the case for Codex Alimentarius, for the USA, Australia/New Zealand, Canada, and the European Union.

DHI has been involved in solving questions whether certain indirect ingredients should be considered eligible for labelling on the final food.

Also, we have investigated characteristics of different food allergens and their occurrence and clinical significance for the consumer. For example, we have investigated whether the allergenicity of pea protein differs between different varieties, namely the yellow and the green varieties.

For more information, please see our report sponsored by Roquette Frères, France.

Contact:

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

The Norwegian Food Safety Authority thinks that allergic reactions and sensitization from cosmetic products should be considered a health risk. So far the EU Commission has attempted to reduce the problem of allergy to certain cosmetic ingredients by mandatory labelling. However, a direct ban on even very potent allergens has been rare.

Up to now the EU Commission has chosen the same approach to allergy to cosmetics as to allergy to food. However, the difference between food allergy and cosmetics allergy is fundamental. Relatively few people develop food allergy whereas most people are able to develop allergic contact dermatitis if exposed to a sufficiently high concentration of cosmetic allergen repeatedly.

Paradox
It is an interesting paradox that the cosmetics legislation states that normal use of a cosmetic product must not cause adverse health effects. On the other hand it is legal to market cosmetic products containing ingredients that may cause sensitization and allergic reactions. The Norwegian Food Safety Authority believes that allergens in cosmetics should be assessed differently from food allergens, because allergens in cosmetics often are intentionally added ingredients unlike food allergens which occur naturally.

Read more here (in Norwegian)

Contact:

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

• GHS - Globally Harmonized System, 12 May
• IUCLID 5 Registration of chemical substances in REACH, 18 June
• Use of nutrition and health claims on food, 12 May
• All courses in 2009 (in Danish)

DHI
Centre for Environment and Toxicology

Agern Allé 5
2970 Hørsholm
Denmark

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

www.dhigroup.com