Chemicals and Regulatory Toxicology Newsletter

June 2017




Chemicals and biocides

10th adaptation to CLP Regulation

The European Commission has published the 10th adaptation to the CLP Regulation on the classification, labelling and packaging of substances and mixtures.

The main changes concern harmonised classification and labelling of hazardous substances (Annex VI) and include:

  • Implementation of new harmonised acute toxicity estimate (ATE) values in Annex VI where relevant
  • Amendments/deletion of some notes to substance classifications
  • Minimum labelling requirements for substances with content of butadiene (note K) or benzene (note P) < 0,1% w/w
  • Amendments to classifications of 16 substances
  • Entry of harmonised classifications for 24 substances (new entries)

View the full details in the Commission Regulation (EU) 2017/776

The requirements will be obligatory from 1 December 2018, but they may be applied before that date.

For more information on substance classification and the CLP Regulation, please consult:

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


Data requirements on by-products from use of disinfectants

Disinfection by-products, particularly chlorate, will have to be given special attention in the evaluation process.

This was one of the important key messages from a workshop on BPR application and re-registration of biocidal products based on active chlorine released from sodium hypochlorite, calcium hypochlorite and chlorine. The workshop was hosted by the Dutch Board for the Authorisation of Plant Protection Products and Biocides (Ctgb) in May and focused on many aspects of the complex BPR applications.

The Ctgb made it clear that in many cases the data requirements and risk assessment on by-products will become quite extensive and also include methods of analysis. In particular, if there is a probability of chlorate formation during storage.

For more information, please contact one of our workshop participants:

Thit Aarøe Mørck
tam@dhigroup.com
Tel +45 4516 9567


New feature on GHS Portal

A new element has been added to our free GHS Portal.

In addition to a wealth of information on GHS and classification and labelling of chemicals, we have added the menu option Other Regulations. Here you can find information on requirements in other regulatory areas. So far, the section includes consumer products, detergents, and placing on the market/manufacturing of general chemicals for a number of major markets. New areas and countries will be added over time.

DHI regulatory database of individual lists of substance information

Are you aware that we also offer a regulatory database of 80 individual lists of substance classifications, national occupational exposure limits and national requirements? If you do business worldwide, it is very important that you are aware of possible national restrictions, prohibitions or specific requirements for substances that are contained in your products.

You can purchase the lists of your particular interest. All individual lists are delivered for direct implementation into your in-house data system.

For more information, please contact:

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


Repeat of 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 and learn more about which products have to be notified, who are obliged to notify products and what information is required.

At the webinar we will also address the new procedure for product notification, which has been amended as of 1 April 2017.

Target group: The webinar addresses both Danish and international manufacturers, as well as suppliers and importers of chemical products to the professional market in Denmark.

Date: Tuesday 19 September at 2 – 3 pm (Danish time, UTC +1)

Sign up: If you want to join the webinar, please send an e-mail to Vibeke Salmon:ves@dhigroup.com


Food and feed

Palm oil should be avoided

There are several reasons to avoid the use of palm oil in food. Palm oil is the vegetable oil containing most contamination from 3- and 2-monochloropropanediol (MCPD), their fatty acid esters, and glycidyl fatty acid esters. These compounds are all bad for human health. Moreover, non-certified palm oil is bad for the environment.

Contamination from manufacturing processes

Esters of 3- and 2-MCPD are formed during the heating of glycerol under the high temperature conditions of deodorisation, a purification manufacturing process. Glycidyl fatty acid esters are carcinogenic and 3-MCPD is toxic to kidneys and the male genital organs. The substance 2-MCPD is toxic to muscle cells in the heart in rat studies, but data on the substance are sparse.

The European Food Safety Authority, EFSA, estimates that the consumption of food with palm oil associated contaminations is too high. This as appears from the EFSA scientific opinion on Risks for human health related to the presence of 3- and 2-monochloropropanediol (MCPD), and their fatty acid esters, and glycidyl fatty acid esters in food.

On the food label, palm oil is listed as palm oil or as hardened vegetable fat from palm oil. Everyday products containing palm oil include hazelnut/cocoa spread, margarine, baby food, and cakes and pastries.

For more queries concerning food contamination, please consult:

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


Authorisation of ethoxyquin as feed additive suspended

As of 28 June 2017, it will no longer be legal to use ethoxyquin as an antioxidant in animal feed. The suspension will apply to all animal species and categories.

Ethoxyquin is widely used in fish meal, fish oil, feed additives preparations etc. However, the additive has not been sufficiently tested to establish that it does not have adverse effects on animal health, human health or the environment. Consequently, the European Commission has decided to withdraw the permission to use ethoxyquin.

Transition period

A limited transition period will be allowed for the withdrawal from the market of products already containing ethoxyquin. For exact withdrawal dates, please refer to the Commission implementing regulation 962/2017 suspending the authorisation of ethoxyquin as a feed additive for all animal species and categories.

For more information, you are also welcome to contact

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


EU consultation on ink in food contact materials

In late 2016, the European Commission announced its plans to harmonise the legislation on coatings, inks and adhesives used in food contact materials (FCMs). According to ChemicalWatch, the Commission has now started consulting with stakeholders in the FCM industry.

The European Printing Inks Association (EuPIA) encourage the implementation of their good manufacturing practice (GMP), including rigorous processes to reduce the risk of non-intentionally added substances (NIAS) migrating from ink.

For more information on FCM, please contact:

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


Life science

Children and chemicals of concern

Unborn children and small children are particularly vulnerable to exposure to chemical substances. In a report from the Danish Environmental Protection Agency, DHI and the National Food Institute evaluated exposure and risk for 37 endocrine disruptors and 39 neurotoxic substances. This is the first time an attempt has been made to assess the overall risk from so many chemicals for this vulnerable age group.

Food is a major source of exposure

For all the assessed substances, the main source of exposure is typically food. Depending on the substance, other important sources of exposure may be the indoor environment (such as dust), the outdoor environment (soil), cosmetics and consumer products including toys.

The highest risk of endocrine disruptors was found in relation to exposure from paracetamol, dioxins/PCBs, phthalates (DEHP, DBP, DiBP), bisphenol A, as well as BHA and BHT. The highest risk of chronic neurotoxic effects was found in lead, dioxins/PCBs, mercury/methyl mercury, bisphenol A and acrylamide. Lead constitutes by far the highest risk as the current exposure of children exceeded the tolerable daily intake with a factor of 50.

Medicinal product has endocrine disrupting effects

The study included a risk assessment of the medicinal product paracetamol, which is the active ingredient in many pain relievers. The assessment showed that the intake of paracetamol during the early stages of development may result in a risk of antiandrogenic (endocrine disrupting) effects.

To assess the effect of the evaluated substances, risk assessments of all substances have been performed using the same principles as for environmental or food-related substances. Risk assessment of medical products will generally be different as medicine may have acceptable side effects. As a result, the Danish Medicines Agency still recommends paracetamol as first-line treatment of pain for pregnant women and children.

The report Exposure of children and unborn children to selected chemical substances has been prepared by DHI, DTU Food/the National Food Institute and Force Technology for the Danish EPA.

For further details, you are welcome to contact the project manager of the report:

Poul Bo Larsen
pbl@dhigroup.com
Tel +45 4516 9478


Parabens and BPA is a poor match

Canadian researchers have demonstrated how some parabens increase exposure to BPA.

The researches wanted to determine how butyl paraben (BP) and propyl paraben (PP) modulates the pharmacokinetics of bisphenol A (BPA). Their study clearly proved elevated concentrations of BPA due to the inhibitory actions of the parabens on the enzymes critical for BPA metabolism.

The research team selected BP and PP for their study, as the Scientific Committee on Consumer Products of the European Commission has previously stated that sufficient data are lacking to complete a safety assessment for these two parabens. Both BP, PP and BPA are used widely in cosmetics and personal care products, as well as in foods, beverages and pharmaceuticals. In previous US surveys, urinary contents of PP were detected in almost all of the population, and BP were detected in half of the population.

Further details in the article Butyl paraben and propyl paraben modulate bisphenol A and estradiol concentrations in female and male mice, published in Toxicology and Applied Pharmacology.

For more information on chemical substances in foods and cosmetics, please contact

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


Assessment of particle emission from candles

Candles are an essential part of the trendy Scandinavian concept of “hygge”. According to surveys, 39% of all Danes burn candles at home daily or almost daily. Candles emit both lead, nickel, scents and other substances and are a significant contributor to high concentrations of indoor particles. In homes burning candles, the main part of the particles in the indoor climate comes from ultrafine particles from the candles. In particular, candles that soot increase the release of larger particles harmful to health.

Avoid soot from candles

In a Danish survey from April 2017 of consumer exposure to candles, the measured levels of lead and nickel did not give any cause for concern of adverse health effects. However, the circumstances of burning candles are considered to be of great significance. A sooting candle can emit 30-70 times larger amounts of carbon particles to the air than a non-sooting candle.

The survey included both candles made of stearin wax and candles of paraffin wax. To conclude whether stearin or paraffin is most critical with regard to particle emission, however, will require more knowledge of the composition of the particles and additional toxicity data. Consequently, to diminish the risk of particle emission the best advice is to burn candles that do not soot.

DHI participated in the survey of candles. You can get more information in the report Survey and Risk Assessment of Particle and Heavy Metal Emissions from Candles or by contacting:

Poul Bo Larsen
pbl@dhigroup.com
Tel +45 4516 9478

Cosmetics

Monitoring of hazardous preservatives in cosmetics

In Europe, ingredients used in cosmetic products must not be harmful to human health according to the EU cosmetics legislation. The legislation aims to protect consumers, whereas it does not include specific environmental requirements to the products. Environmental requirements are regulated through the EU chemicals regulation, REACH.

The Swedish Chemicals Agency, KEMI, has examined the use of triclosan and 18 other preservatives in cosmetics. The substances are used in soap, shampoo and other cosmetic products and can harm the environment when wastewater is discharged to the aquatic environment. In particular, chlorinated preservatives can be harmful as some are persistent, bioaccumulative and highly toxic to aquatic environments. According to the report from KEMI, the amount of environmentally harmful preservatives is low in cosmetic products on the Swedish market. However, preservatives are also part of other everyday products that can contribute to environmental impacts.

Measures to control use

KEMI proposes a number of measures to curb the use of certain preservatives in everyday products. These measures include criteria for the public procurement of cosmetic products and environmental monitoring of the substances. Furthermore, KEMI proposes to increase the support to companies that want to replace problematic preservatives with better alternatives.

More details are available in KEMI’s report (in Swedish; English summary on pages 8–9)

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


Courses

Free webinar: Notification of chemical products in Denmark – 19 September

Applied Toxicology – Two-day theoretical course – 20 and 21 September – Hørsholm, Denmark

For more information on courses and registration, please visit The Academy by DHI


Meet us at

Eurotox 2017, Slovak Republic
Chief Toxicologist Poul Bo Larsen participates in Eurotox 2017, the 53rd Congress of the European Societies of Toxicology, to be held in Bratislava, Slovak Republic, on 10-13 September.

Nordic Chemicals Summit 2017, Sweden
Senior Chemicals Consultant Jens Tørsløv will chair one of the sessions at the Nordic Chemicals Summit taking place in Gothenburg, Sweden on 12-13 September. You can also meet us at our stand.

Regulatory Summit Asia 2017
Jens Tørsløv together with Business Development Manager Brian S. Nielsen will also participate in the Regulatory Summit Asia 2017 commencing on 20 November. Together with our partners from Korea Institute of Science and Technology (KIST) we will be hosting a stand. Further details of the event are not yet available.


Contact

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Tel: +45 4516 9200 | Fax: +45 4516 9292 | www.tox.dhigroup.com



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