Newsletter on Chemicals and Regulatory Toxicology

September 2018

Chemicals and biocides

California – new product warning requirements

New requirements for product warnings in the US state of California became effective as of 30 August 2018. This is the result of an amendment of Article 6, Clear and Reasonable Warnings of the Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as California Proposition 65.

Proposition 65 requires businesses to provide warnings to users about significant exposures to chemicals that cause cancer, birth defects or other reproductive harm. For certain specific products such as food, beverages and dental care products, separate warnings are required. The new regulation places the primary responsibility for providing warnings on product manufacturers, producers, packagers, importers, suppliers and distributors.

Consumer products manufactured before 30 August 2018 and labelled with warnings according to the previous regulation (2008) are deemed compliant with the requirements of the 2018 version and do not need new warnings.

For more information, please contact:

Ilaria de Rosa Carstensen
Tel +45 4516 9369

Australia – new classification guide

Safe Work Australia has updated the guidance on classification of hazardous chemicals according to the Work Health and Safety (WHS) Regulations that implements GHS in Australia. The new guidance is enriched with examples of classification of substances and mixtures, based on different approaches, which will help companies when classifying chemical products.

The document also contains links to databases with information on chemicals that can be useful, especially for SMEs, when collecting data on hazardous substances for the purpose of classification.

For more information on classification of chemicals, please contact:

Ilaria de Rosa Carstensen
Tel +45 4516 9369

Free webinar: Notification of chemical products in Denmark

Chemical substances and mixtures placed on the Danish market may be subject to product notification to the Danish Working Environment Authority. Join our free webinar on 2 October and learn more about which products have to be notified, who are obliged to notify products and what information is required.
Read more here.

Circular Economy

EU public consultation on circular economy

If you want to have a say in EU’s policy on circular economy, the European Commission invites all interested parties to participate in a public consultation about the interface between chemical, product and waste legislation. The consultation runs until 29 October 2018.

The Commission has identified four critical issues in the way the legislation on chemicals, products and waste work together and wants to explore how these are hampering a circular economy development:

  • Information on presence of substances of concern is not readily available to those who handle waste and prepare it for recovery
  • Waste may contain substances that are no longer allowed in new products
  • EU's rules on end-of-waste are not fully harmonised, making it uncertain how waste becomes a new material and product
  • Rules to decide which wastes and chemicals are hazardous are not well aligned and this affects the uptake of secondary raw materials

More information and questionnaires are available in 23 EU languages, read here.

For questions about circular economy, please contact:

Margrethe Winther-Nielsen
Tel +45 4516 9320

Life science

Danish EPA warns against squishy toys

In June the Danish Environmental Protection Agency (EPA) issued a strong warning against the popular squishy toys and recommended avoiding the products altogether. This caused quite a stir as squishies have been hugely popular. The EPA’s warning was the result of a survey initiated because of repeated enquiries about the strong and unpleasant smell from squishies.

In the survey, the degassing of chemical substances from 12 squishies was analysed and evaluated. The survey also included a screening of the risk of children’s contact with the toys. The substance release was evaluated in two worst-case exposure scenarios. In the first scenario a child is sleeping with a squishy toy; in the other degassing from 40 squishies in the same room was evaluated.

Degassing exceeded sampling equipment
More than 40 different chemical substances were found when the 12 squishies were analysed. In some cases the degassing was so strong that it exceeded the capacity of the sampling equipment. A screening of the health hazards of the substances was compared to the degassing levels and revealed a highly increased health risk for all the screened squishies.

Substances harm eyes and respiration
The risk of exposure was high, both for acute and long-term impacts, particularly concerning damage to the mucous membranes of the eyes and respiratory tract. The impact was most critical in the scenario with the child sleeping with a squishy in his/her arms. However, the scenario with degassing from several squishies in one room also showed increased risk, even if the number of squishies in the room was far below 40.

Because of the risk to children’s health, the Danish EPA issued a warning against squishies and declared all the 12 squishies in the survey as illegal and withdrew them form the market.

An English summary of the survey is available in the report published by the Danish EPA (pages 13-19). The risk screening was carried out by our toxicological team based on measures made by the Danish Technological Institute.

For more information, please contact:

Poul Bo Larsen
Tel +45 4516 9478

Safety of toys
If you are in doubt about the safety of toys and release of chemicals that may impair children’s health, we can guide you, including advice on which information you should request from your suppliers.


Lise M. Møller
Tel +45 4516 9133

Feminine hygiene products are safe

In a risk assessment of tampons, sanitary towels, panty liners and menstrual cups, chemicals were identified at very low concentrations. The concentrations do not exceed any health thresholds concludes ANSES, the French health agency, which carried out the assessment.

Although the assessment did not reveal any cause for concern, ANSES recommends that the chemical content in feminine hygiene products should be reduced as far as possible. Furthermore, ANSES supports a regulatory framework at EU level to limit the presence of chemicals in hygiene products. Despite the widespread use of these type of products, there is no specific EU regulation for their manufacture or use.

ANSES also examined the risk of menstrual toxic syndrome (TSS), a rare but potentially serious risk associated with tampons and menstrual cups. The risk of bacterial growth is increased if the user forgets to change internal feminine hygiene products. As a result, ANSES recommends that better information is provided on packaging.

For more information, please contact:

Helle Buchardt Boyd
Tel +45 4516 9097


New advice on pesticide residues in baby food

Maximum levels of certain types of pesticide residues should be revised for infants under 16 weeks.

Following a 2017 guidance on the risk assessment of substances in baby food and the latest new evidence on developing systems in infants and young children, the European Food Safety Authority (EFSA) has evaluated the safety of pesticide residues in baby foods.

EFSA recommends revision of the maximum level of certain types of pesticide residues and that specific safe intake levels are established for infants under 16 weeks. More information in EFSA’s Scientific opinion on pesticides in foods for infants and young children.

For infants older than 16 weeks, the current protective measures are still considered appropriate.

For more information on residues in food, please contact:

Helle Buchardt Boyd
Tel +45 4516 9097

Accidental food allergy reactions

People with food allergy cannot merely rely on food labelled with a “may contain” precautionary allergen labelling (PAL). Both food products with and without PAL-labelling may contain undeclared allergenic ingredients

This is evident from a Dutch study of Accidental food allergy reactions: products and undeclared ingredients, in which 157 persons with food allergy reported accidental allergic reactions during a one-year-period. The largest concentrations of undeclared allergens were milk, peanuts and sesame. These are all regulated by the European food legislation and on the list of allergens for which labelling is mandatory.

In some cases, up to four culprit allergens were identified in a product. The most common culprit food products were bread, cookies, chocolates, meat and fruit. Contamination often happens during processing, storage or transport.

For questions on food allergens, please contact:

Helle Buchardt Boyd
Tel +45 4516 9097

Information about the EU GDPR

Information about the General Data Protection Regulation (GDPR)

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