News about Environment and Toxicology

May 2013


Chemicals

Chromates on REACH Authorisation List

By mid-April eight new substances were included on Annex XIV of the REACH regulation. The Annex is also known as the Authorisation List as the use of substances on this list is subject to authorisation.

Among the new substances on the List are a number of chromates and dichromates, which are often used in chrome plating to protect metals from corrosion and to improve paint adhesion.

The eight substances comprise the following:

  • Ammonium dichromate (CAS no. 7789-09-5)
  • Potassium chromate (CAS no. 7789-00-6)
  • Acids generated from chromium trioxide and their oligomers
    Group containing: Chromic acid, Dichromic acid, Oligomers of chromic acid and dichromic acid (CAS no. 7738-94-5, 13530-68-2)
  • Chromium trioxide (CAS no. 1333-82-0)
  • Potassium dichromate (CAS no. 7778-50-9)
  • Sodium chromate (CAS no. 7775-11-3)
  • Sodium dichromate (CAS no. 7789-12-0; 10588-01-9)
  • Trichloroethylene (CAS no. 79-01-6)

See latest date for authorisation application and sunset date on the Authorisation list here.For more information, please contact

Anne Rathmann Pedersen
arp@dhigroup.com
Tel +45 4516 9370

Aerosol labelling adapts to CLP

Following an amendment of an EU Directive in March, aerosol dispensers are to be classified, labelled and packaged in accordance with the CLP Regulation. In brief, the new Directive stipulates as follows:

  • Aerosols (whatever their contents) shall always be marked with specified hazard and precautionary statements
  • An additional precautionary statement (P102) to be included if the aerosol dispenser is a consumer product
  • Non-flammable aerosols shall bear the signal word Warning
  • Flammable aerosols shall bear the signal word Warning as well as all other label elements for Flammable Aerosols Category 2
  • Extremely flammable aerosols shall bear the signal word Danger and all the other label elements for Flammable Aerosols Category 1
The above provisions will enter into force on:
  • 19 June 2013 as regards aerosol dispensers containing a substance
  • 1 June 2015 as regards aerosol dispensers containing mixtures

To view the full Commission Directive 2013/10/EU, please read here.

For more information, please contact

Ilaria de Rosa Carstensen
idc@dhigroup.com
Tel +45 4516 9369

Compulsory labelling of biocidal products by 1 September

Suppliers and distributors of products with anti-microbial or self-sanitising properties should pay particular attention to the above date. By 1 September biocidal products have to carry special labelling that helps the consumer understand the products' anti-microbial action. What is more, the EU Biocidal Products Regulation stipulates that the labelling has to be written in the country's national language.

Approval only valid for specific use
The EU is currently evaluating some of the most common anti-microbial substances, and some have been turned down and forbidden from the market. As a supplier or distributor, you should also be aware that anti-microbial substances are approved for specific uses and not for use in general. Thus, a repellent substance approved for use in mosquito nets might not be allowed as a repellent in clothing.

For more information, please refer to our website or contact

Michael Fink
mif@dhigroup.com
Tel +45 4516 9156

Food

Toxin warning for algal dietary supplements

In a recently published study by German researchers, commercially available algal dietary supplements were analysed for occurrence of toxins. Three different algae are used for production of dietary supplements: Aphanizomenon flos aquae (AFA), Chlorella sp. and Spirulina sp. They are all cultivated outdoors in large lakes or in open pond systems sensitive to contamination.

Not for children
Based on the provisional tolerable daily intake (pTDI), infants (5 kg), children (20 kg) and adults (60 kg) may tolerate a maximum exposure of 0.2, 0.8 and 2.4 μg microcystin (MC) per day, respectively. In the German study, the highest level of microcystin (MC-LR*) found was 11 µg/g dry matter. MC-LR is a common hepato-toxin in blue-green algae and is considered a potential human carcinogen. The study showed that nearly all algal dietary supplements containing AFA on the German market exceed the daily tolerable exposure of microcystin (MC) for infants. Moreover, all pure AFA-based dietary supplements exceed the daily tolerable exposure of MC for children.

Revision of intake-levels expected
Health risk assessments for the effects of MCs have not taken into account possible neurotoxic effects from long-term intake or the possibility of combined exposures or cocktail effects. As a result, the pTDI is likely to be revised. Other sources of MCs are drinking water and seafood.

BMAA - another toxic algae
Another toxic substance connected to blue-green algae is the neurotoxic amino acid BMAA (beta-N-metylamino-L-alanin), produced by both freshwater, brackish and marine blue-green algae. BMAA has been shown to cause nerve cell death and neurodegenerative changes in rats exposed as neonates. Higher levels than in algae have been found in zooplankton, shellfish and bottom-dwelling fish. It seems that this toxin is concentrating in the aquatic food chain.

The study Toxin content and cytotoxicity of algal dietary supplements has been published in Toxicology and Applied Pharmacology.

If you need help with risk analysis and establishment of HACCP programmes or advice on the production and marketing of algae, food supplements or seafood, please contact:

Ann Detmer
ad@dhigroup.com

*Microcystins are cyclic heptapeptides, more than 100 microcystin congeners are now known. The most common congener and one of the most toxic is MC-LR. MC-LR is the only microcystin with a pTDI.

Guidelines for health claims

Many wrongly believe that you are not permitted to use health claims on certain foods. As a result, the European Commission has prepared a guideline for the use of health claims. In some EU countries, authorities seem to interpret the regulations more rigorously than in other countries, but the regulation is in fact the same in the entire EU.

You are allowed to claim that a food is healthy if you make this unspecific claim in combination with an approved specific health claim, which explains the healthiness of the food, provided the conditions for using the claim are fulfilled.

Health claims also on signboards
Health claims are not limited to labels or stickers on wrapped or packaged food. Health claims may also be used on store signboards and in marketing materials provided that it complies with the stipulated conditions. This includes stressing the importance of a varied and balanced diet and a healthy lifestyle, and information on the quantity of the food required to obtain the claimed beneficial effect.

View the EU guidelines for the implementation of specific conditions for health claims.

For questions on health claims, please contact

Helle Buchardt Boyd
hbb@dhigroup.com
Tel +45 4015 9097



New maximum levels for dioxin and PCB in liver

The European Commission has proposed an amendment of the regulation regarding maximum levels for dioxins and PCBs in liver. Until now the limit value in liver has been measured in pg/g fat. With the amendment the value should be measured in pg/g wet weight. This will make the analysis results more comparable as the fat content in the liver may vary considerably.

Separate maximum level for sheep liver
A separate limit value is proposed for sheep liver. Compared to cattle, sheep livers seem to be an important organ for storing of dioxins and PCBs. Consequently, people eating sheep livers may have intakes of dioxin approx. 20% above the usual intake. Grazing animals are exposed to PCBs by intake of soil when biting off the grass.

The new proposed maximum levels for dioxins and dioxin-like PCBs in sheep liver are four times higher than for other terrestrial animals. For non dioxin-like PCBs, the proposed maximum levels are the same for both sheep liver and liver from other terrestrial animals.

For more information, please contact

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



Gluten intolerance can be prevented

A Swedish study shows that celiac disease (gluten intolerance) can be prevented.

If you are diagnosed with celiac disease, you have to avoid gluten in your diet for the rest of your life. Sweden has the highest occurrence of celiac disease in Europe, even higher than in the USA. During a ten-year-period from about 1984, Sweden experienced almost an epidemic of celiac disease in toddlers. This was the result of an inappropriate diet. New data from the Swedish epidemic and other studies show that gluten intolerance can be significantly prevented by breastfeeding and by gradually introduce gluten-containing foods from 4 months of age during on-going breastfeeding.

The results have been published in the article Prevalence of Childhood Celiac Disease and Changes in Infant Feeding in the American scientific journal Pediatrics. For more information on labelling of gluten free products or product containing gluten, please contact

Ann Detmer
ad@dhigroup.com



Looking to substitute phthalates in food contact materials?

Although some phthalates are permitted in food contact materials, the use of phthalates is restricted. In addition some phthalates are included in the REACH Candidate List of substances of very high concern (SVHC). You may find it peculiar that it can be legally acceptable to use SVHC substances in food contact materials; however, the good news is that you can substitute the phthalates with other substances.

DHI is participating in a project for development of methods to substitute phthalates. For this purpose, we are looking for companies who are not sure how to overcome the various hurdles of substitution and how to find substances that are safe to use with regard to human health and the environment.

If you have a relevant case and wish to present it to us, we should be pleased to hear from you. Naturally, we will provide confidential disclosure agreements to all participants.

For more information, please contact

Helle Buchardt Boyd
hbb@dhigroup.com
Tel +45 4015 9097



Cosmetics

France wants to tighten use of phenoxyethanol in cosmetics

France wants to lower the threshold limit value for phenoxyethanol, which is used as a preservative in cosmetic products.

In 2012 the French national agency for medicines and health products safety, ANSM, evaluated the risk of phenoxyethanol in cosmetics. They concluded that the current permitted concentration of 1% in skin care products does not sufficiently protect children. Consequently, ANSM has recommended to the EU Commission that the maximum concentration in products for children under three years of age the use of phenoxyethanol should be reduced to 0.4%. Furthermore, the ANSM recommends that phenoxyethanol should not be used in products intended for the nappy area.

Popular substitute for parabens
Phenoxyethanol is a preservative. It is neither classified as allergenic or as an endocrine disruptor. However, in animal testing the substance has shown damage to the liver after extended periods of use. The substance is common in cosmetics because parabens have been removed from many products. The substance can also be found in “green” products including products with the Nordic Swan labelling or the EU Ecolabel.

A risk evaluation of phenoxyethanol (in French) is available here.

For more information, please contact

Estelle Giovalle
egi@dhigroup.com
Tel +45 4516 9205

EU ban on cosmetics tested on animals

On 11 March a full marketing ban on cosmetics tested on animals entered into force in the EU.

The ban was implemented, even though the EU Commission acknowledges that it is not yet possible to fully replace animal testing by alternative methods. However, with the ban the Commission wants to further responsible innovation and to meet a strong consumer wish for a ban on animal testing. The ban comprises both cosmetics tested on animals and products containing ingredients which have been tested on animals.

The ban has been implemented gradually since 2004.

Pay attention when importing cosmetics to the EU
Importers and distributors to the EU market should ask producers to verify that products or ingredients have not been tested on animals outside of the EU after the following prohibition dates:

  • 11 September 2004 (products)
  • 11 March 2009 (ingredients) or
  • 11 March 2013 (animal tests with earlier dispensation)

Ann Detmer
ad@dhigroup.com

Courses

Courses and seminars in Denmark
Browse all our courses and seminars in Danish here and English here.

Courses Asia-Pacific region
Read more about our many courses in the Asia-Pacific region here.


Meet Us

SETAC Europe, Glasgow, UK
Margrethe Winther-Nielsen and Morten Bjergstrøm will participate in the 23rd Annual Meeting of the Society of Environmental Toxicology and Chemistry on 12-16 May. DHI has submitted two posters for the Annual Meeting.

The XIII International Congress of Toxicology 2013, Seoul, South Korea
Helle Buchardt Boyd will be participating in the ICT 2013 which will be held in Seoul, South Korea on 30 June 30 ~ 4 July.

Contact

DHI | Agern Allé 5 | 2970 Hørsholm | Denmark
Tel: +45 4516 9200 | Fax: +45 4516 9292 | www.tox.dhigroup.com



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