News about Environment
and Toxicology

December 2015




Chemicals

ECHA offers easier access to information and registration in 2016

The European Chemicals Agency (ECHA) has the most exhaustive information database of chemical substances. It is already possible to access non-confidential information and in 2016, ECHA will create a special web page to make access even more user-friendly. Through the new web page, it will be possible for consumers or companies to obtain short substance specifications (Info Card). If you are interested in more detailed specifications, these will be available through a brief substance profile (Brief Profile). Finally, the web page will offer a complete and detailed overview of available substance data as well as the legal requirements on the individual substances.

Online registration
The improved access is part of ECHA’s ongoing activities to update their portals and its tools. In addition, it will be made possible to register substances online, i.e. without local installation of the IUCLID database. This may be relevant for registrants who are part of a joint substance registration and who only need to submit company specific data.

For more information, please contact:

Jens Tørsløv
jet@dhigroup.com
Tel +45 4516 9022


Strengthening the OSOR principle: One Substance One Registration

With an upcoming Implementing Regulation on data sharing from the European Commission, ECHA has been given the task to strengthen the implementation of the OSOR principle (One Substance One Registration). The regulation is to ensure effective application of REACH with regard to the data sharing process. The draft implementing regulation holds provisions on transparency in data sharing and in data sharing agreements along with provisions on fairness and non-discrimination for cost sharing.

ECHA to resolve disputes
The regulation will limit the individual submissions by helping registrants of the same substance to agree on data sharing and by ensuring a proportionate way forward for registrants who are blocked in the SIEF process (Substance Information Exchange Forum). However, a full or a partly opt out from the joint submission is still possible. In case of disputes, ECHA has the mandate to resolve.

Easier to clarify same substance identity
With the introduction of a new substance identify profile, it will also be easier to clarify same substance identity and to identify and confirm co-registrants of same substance in the pre-SIEF process.

Strengthening the OSOR principle was one of the topics discussed at the ECHA session in November in Brussels on upcoming changes in tools and processes involved in the registration of substances under REACH.

For more information, please contact session delegate:

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


DHI secures Article 95 listing for ECA Consortium

DHI has worked hard for the ECA Consortium in order to get the members listed as alternative suppliers of active chlorine generated from sodium chloride under Article 95 of the European Biocidal Products Regulation. DHI has performed all the technical work related to the dossier including data generation, data sharing and project management.

In early December 2015, the final decision was taken by ECHA and an approval was granted which secures the future business of the consortium members. The ECA Consortium currently consists of 14 members (EU and non-EU). The group places devices on the European market that generate active chlorine through electrolysis of brine. The group also has six associated members that are involved in the production of sodium chloride. Read more about the consortium here.

According to Article 95, a biocidal product cannot be made available on the EU market unless either the substance supplier or the product supplier is included in the Article 95 list.

For more information, please contact:

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


Additional labelling of epoxy constituents and isocyanates

We regularly notice that suppliers of chemicals are not aware that the criteria for some supplementary labelling have changed according to the previous labelling rules.

Previously, products containing epoxy constituents or isocyanates had to be labelled Contains epoxy constituents. See information supplied by the manufacturer or Contains isocyanates. See information supplied by the manufacturer, respectively.

The above phrases do not exist in the CLP Regulation. You should use the following phrases instead:

  • EUH205: Contains epoxy constituents. May produce an allergic reaction.
  • EUH204: Contains isocyanates. May produce an allergic reaction.

The phrases are used for labelling of products containing epoxy constituents or isocyanates, but they should ONLY appear from the label if this information is not already evident on the labelling. In other words, if the product is already classified and labelled as sensitising and the name of the sensitising substance is indicated, then it is not necessary to state EUH204 or EUH205 on the label.

Cement products and chromium
The same rule is applicable for cement products. The sentence EUH203: Contains chromium (VI). May produce an allergic reaction is only to appear from the labelling, if the product is not already classified as sensitising and labelled with the sentence H317.

If you have questions concerning the CLP Regulation and labelling, please contact:

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


Course on new OECD QSAR Toolbox Version 3.3.5

Recently, a new version of the OECD QSAR Toolbox was released. The Toolbox is a software application for filling gaps in (eco)toxicity data needed for assessing the hazards of chemicals. The new Version 3.3.5 contains the following updated features:

  • updated endpoints vs. endpoint correlation
  • addition of chemicals IDs in expert function
  • updated databases
  • enhancement of the usability of the Toolbox for regulatory purposes such as REACH registrations

It is possible to directly export and import files between the Toolbox and IUCLID. Furthermore, it is also possible to perform queries to compare different chemicals, for example for their (eco)toxicological properties.

Senior consultant Hülya Genc Fuhrman recently participated in a three-day Advanced and practicum Training for the newly released Version 3.3.5. Hülya hosts a course on the OECD QSAR Toolbox on 14 January. To learn more, read here.

For more information on QSAR and the QSAR course, please also contact

Hülya Genc Fuhrman
hgf@dhigroup.com
Tel +45 4516 9256


Life science

Risk from consumer use of nanomaterials

Overall, the use of consumer products containing nanomaterials can be considered safe. This is the conclusion of a thorough consumer risk assessment for nanoproducts on the Danish market. The study comprises four reports. The final report covers risk assessments of a representative set of consumer products containing nanomaterials such as food items, food supplements, sunscreens and other cosmetics as well as various chemical products.

The reports covered the following subjects:

Exposure assessment
In report no. 1636 current exposure models are evaluated in detail for their applicability for nanomaterials in consumer products. No overall model(s) could be selected and instead the most critical parameters for exposure assessment were identified. Based on this knowledge, 20 exposure scenarios were performed for a representative set of consumer products containing nanomaterials.

Exposure from the environment
In report no. 1633 exposure to ultrafine particles in ambient air and indoor air was assessed and exposure levels were compared to exposure levels from nanomaterials in consumer products. Only in exceptional cases did the exposure from consumer products exceed the exposure to ultrafine particles from outdoor and indoor environment. It was concluded that the high risk of adverse health effects from ultrafine particles in ambient air should not be taken as an indication of risk of nanomaterial exposure from consumer products, as the toxicological data did not support read-across from ambient air particles to nanomaterials in consumer products.

Consumer risk assessment
In report no. 1730, exposure assessments (report 1636) and hazard assessments (report 1637) were integrated into risk assessments of the 20 consumer exposure scenarios covering seven different nanomaterials. The conclusion was that generally the use of consumer products with nanomaterials can be  considered safe.

Risk could only be identified in rare cases such as scenarios covering sanding and spray-painting. However, the risk in these scenarios not only pertained to the exposure to nanomaterials but also to the exposure of larger particulates.  Overall, inhalation was considered as the most critical route of exposure to nanomaterials as scenarios with spray products and similar indicated possible concern. However, great uncertainty still remains concerning assessment of inhalation exposure whereas oral and dermal exposure may be more easily predicted.

The projects have been carried out by DHI in co-operation with COWI A/S and the Danish National Research Centre for the Working Environment (NRCWE) and were financed by the Danish Environmental Protection Agency.

For questions regarding nanomaterials or the above reports, please contact:

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


Food

Risk profile for insects used as food and feed

The European Food Safety Authority (EFSA) has published a risk profile for use of insects as food and feed. The awaited EFSA publication is one small step towards the legal use of insects as food and feed. Many identified data gaps require new results from both applied studies and basic research. However, interested parties can use EFSA’s risk profile to pinpoint necessary research.

View EFSA’s Risk profile related to production and consumption of insects as food and feed

Insects are novel food in EU
In the European Union, insects fall within the definition of novel foods. This includes both whole insects as well as parts of insects (legs, wings, heads, etc.). This is clearly clarified in the Novel Food Regulation agreed in November 2015. The new regulation is expected to enter into force around end 2017. For more information on the new Novel Food Regulation, click here.

If you require help with research of insects as food and feed, you may contact:

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


Peanuts in food usually labelled

The work concerning labelling criteria for “May contain traces of ......” is still ongoing. At present, the detection limit for peanuts cannot be lower than 2 ppm peanut protein. In addition, the risk of hot spots of peanut particles in inhomogeneous foodstuff should be added.

Almost 100% correct labelling
In a joint research project, the largest study so far of its kind, a total of 899 samples were tested for traces of peanuts. Many food companies that process peanuts in parallel or use peanuts in other products often label their products “May contain traces of ......”, even if peanuts are not a regular ingredient of a food recipe. In the study traces of peanut were detected in only nine of the 899 samples (~ 1 %). Only two products that did not have a warning were tested positive for traces of peanut. The traces were, however, only just detectable (about 1 mg/kg). Consequently, 99.7% of negative samples were labelled correctly.

For more detailed information, download the report: Peanut traces in packaged food products consumed by allergic individuals

The joint project was carried out by the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) and the German Federal Institute for Risk Assessment (BfR).

For more information on food allergens, please contact:

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


Inconclusive assessment of feed additive antioxidant

In a re-assessment of the feed additive ethoxyquin, EFSA has not been able to reach a conclusion due to an overall lack of data. Ethoxyquin is used in animal feed for its antioxidant properties and in fish meal to prevent spontaneous combustion at sea.

During the re-assessment, EFSA found that one of the substance’s metabolites could be genotoxic and damage DNA. Moreover, after the manufacturing process an impurity remains in the feed additive which is a possible mutagen and may cause genetic mutations in both animals and humans.

Download the scientific opinion from EFSA here: Safety and efficacy of ethoxyquin (6-ethoxy-1,2-dihydro-2,2,4-trimethylquinoline) for all animal species

Alternatives to ethoxyquin exist. In feed for organically farmed fish, only tocopherol-rich extracts are permitted as antioxidant.

For assistance on feed additives and alternative antioxidants, please contact:

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


High metal release from espresso machines

In a research paper published in October 2015, the release of metals from eight coffee machines was investigated. Metal release proved to be a problem, in particular in connection with decalcification. The highest leaching was found for the portafilter espresso machines and in amounts beyond the release limits proposed by the Council of Europe (CoE). Consequently, careful rinsing routines after decalcification are recommended. Of particular concern was leaching of lead (Pb) at levels causing health concern. Other metals released from the tested machines were manganese (Mn), chromium (Cr), zinc (Zn) and nickel (Ni).

One machine below release limits
One portafilter machine in the survey, however, did not release any elements at concentrations causing concern. Consequently, it is technically possible to produce machines that comply with the CoE guidelines.

The release of metal ions and toxic alloying components is an ongoing problem in food contact materials. Currently, European law has no release limits concerning the leaching of elements from metallic food contact materials except for general requirements that releases must not endanger human health. In a resolution passed by CoE in 2013 on metals and alloys, specific release limits have been proposed for 21 metals and metalloids.

Download the article here: Metal release from coffee machines and electric kettles

For more information on food contact materials, please contact:

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

Courses and webinars

Webinar: Notification of chemical products in Denmark - 19 January
Chemical substances and mixtures on the Danish market may be subject to product notification to the Danish Working Environment Authority. Join our free webinar and learn which products have to be notified, who are obliged to notify products and what information is required.
Date: Tuesday 19 January 2016 at 3 pm – 3.45 pm (Danish time, UTC +1)
To sign up for the webinar, please send an e-mail to Vibeke Salmon: ves@dhigroup.com

See our remaining courses (in Danish) on our website.


Contact

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



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