News about Environment and Toxicology

Feb 2014


Chemicals

High non-compliance level in 2010 registration dossiers

ECHA, The European Chemicals Agency, has completed the compliance check of selected registration dossiers from the 2010 registration deadline. Of these, 69% of the dossiers were found to be non-compliant. Non-conformity was mainly because of deficiencies in the substance identity, insufficient justification for not submitting required studies or missing information in the chemical safety report.

Responsibility lies with the individual registrant
The registrants of the non-compliant dossier will be required to provide the missing information within an individually set deadline. This could include anything from clarification of issues pertaining to the substance identity to the initiation of required studies.

It should be noted that it is the obligation of the individual registrant to provide the missing information and to update the dossier. With respect to shared data, this can be done in co-operation with the other registrants submitting jointly. Registrants, who have relied on a letter of access, should consult their agreement and check if they are entitled to updated versions of the dataset, and if an update is available.

Check dossier information yearly
The registration dossier is intended as a living document, and we recommend that the need for updating is checked on a yearly basis. In general, the registration dossier is the documentation of safe use in the supply chain and basis for all interaction on REACH with the authorities. This would include possible further regulatory initiatives, e.g. inclusion on the candidate list. Industry should be aware that the best position in discussion with authorities on such matters is an up-to-date dossier and Chemical Safety Report.

For more details on registration of chemicals, please consult

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

In-situ generated biocidal active substances

The European Commission has published a note aimed at gathering information on in-situ generated biocidal active substances and on the chemical substances (i.e. the precursors) that may be used to generate them. The information collected will be used to decide on how to manage in-situ generated biocidal active substances in the context of the EU Biocidal Products Regulation.

For further details, please refer to the Commission’s letter. Information should be submitted to the European Commission by 31 March 2014.

For more information on the Biocidal Products Regulation and biocidal active substances, please contact

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

Biocidal active substances: similarity check service

ECHA reports that it offers chemical similarity checks as a new service to industry. The similarity check will be performed solely on the substance identity and chemical composition. The aim is to establish the similarity between two or more sources of the same substance in the following situations:

  • When comparing the source of an active substance to a biocidal active substance which has been submitted for assessment but for which final decision on the approval has not yet been adopted.
  • When comparing two or more sources of the same active substance (which are generally not under evaluation), with a view to a possible joint application for an active substance approval.

The chemical similarity check is voluntary and subject to a charge. More information will be available on ECHA’s webpages.

For more information on biocides, please contact

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

Co-formulants more toxic than glyphosate

Glyphosate is one of the most common active ingredients in plant protection products used worldwide to prevent unwanted plant growth or to accelerate the ripening process of crops. BfR, the German Federal Office for Risk Assessment, has evaluated more than 1,000 new studies and reassessed the health risks associated with glyphosate. This thorough examination does not warrant any significant changes in the limit value of the active ingredient.

However, the environmental toxicity of certain glyphosate-containing products can be higher than that of the active ingredient alone, on account of co-formulants. One such is the surfactant group of polyethoxylated tallow amines. This fact will be taken into account when approving new glyphosate-containing products.

A public hearing of glyphosate will be carried out by EFSA in 2014.

For more information on glyphosate and plant protection products, please contact

Ann Detmer
ad@dhigroup.com

Methanol: harmonised classification proposed

Italy has proposed an addition to the harmonised EU-classification of methanol. Scientific studies suggest that methanol has adverse effects on the development of the foetus. As a result, a harmonized classification as toxic to reproduction has been proposed.

Methanol is used in the production of many household products and as a solvent in, for example, paints and car cleaning products.

A public consultation of the Italian proposal on harmonized classification has been held. The proposal is now to be evaluated by an EU expert committee.

For more information on methanol or classification on chemicals, please contact

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

Guidance on how to limit phthalates of concern

In a new Danish business guidance it is recommended that as far as possible phthalates of concern are to be avoided.

The aim of the guidance is to give advice on a voluntary effort by helping you to get started with the process of assessing whether phthalates of concern can be avoided or limited. The guidance also provides instructions on how the necessary dialogue with your supplier can be approached.

Click to view Business guidance on phthalates. How to limit phthalates of concern in articles?

The guidance has been made by DHI in collaboration between the Danish EPA and a number of industry associations.

For more information on phthalates of concern, please contact

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

Webinars on emergency response and Chinese chemicals regulations

In 2014 together with our UK partners NCEC, we offer webinars on international chemicals regulation.

The first webinar hosted by NCEC takes place on 25 February and will focus on two topics: Emergency response best practice and Chinese chemicals regulations.

For more details and to register, please read here.

Later, DHI will host a seminar on exposure scenarios.

For more information on webinars, please contact

Helle Westphal
hw@dhigroup.com
Tel +45 4516 9012

Food

Bisphenol A: EFSA lowers TDI

EFSA, the EU food safety authority, has lowered the tolerable daily intake (TDI) for Bisphenol A (BPA) with a factor 10. The decision is based on reviews of the potential health hazards associated with BPA from more than 450 studies, including new studies.

EFSA’s experts recommend that the TDI be lowered from its current level of 50 µg/kg bw/ day (or 0.05 mg/kg/bw/day) to:

  • 5 µg/kg bw/day (0.005 mg/kg/bw/day)

The potential risks of BPA to health and the environment are well-known and often far better investigated than possible alternatives. This makes it difficult to identify alternatives.

Public consultation
The regulation of BPA differs in various EU-membership countries. As the only country in the EU, France has adopted a ban against BPA in all food contact materials effective from 2015. In Denmark, BPA has been included on a list of undesirable substances.

EFSA has launched a public consultation on BPA that runs until 13 March 2014. For more information, please read here.

Questions concerning BPA can be addressed to

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

New list of permitted primary smoke aromas now in force

As of 1 January 2014 the positive list of primary smoke aromas is in force.

Ten smoke flavouring primary products have been approved for use in food by EFSA, the European Food Safety Authority. The smoke flavourings can be used directly in food or to make derived smoke flavourings for use in snacks, spice blends, and so on.

DHI has contributed to the work with seeking approval of the smoke flavouring primary products.

View the regulation and list of authorised smoke flavouring primary products.

For more information, please contact

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

New draft regulation on novel foods

Easier access to the EU market for foods with a history of safe use in non-EU countries and ensuring consumer protection is the aim of a new draft regulation on novel food.

Under the draft regulation, the authorization procedure for novel foods will be simpler and more efficient. Further, the regulation will protect innovation of novel food when the innovation is supported by newly developed scientific data, such as safety testing and manufacturing methods. This includes a 5-year period for the benefit of the applicant before the food can be marketed by other companies.

View the proposal for a revised regulation on novel foods.

The draft legislation was adopted by the European Commission in late 2013, and is not expected to enter into force until 2016 at the earliest.

For more information on novel food regulation, please contact

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

Still high levels of acrylamide in food

Despite the fact that the EU is preparing new limit values for acrylamide, the level of acrylamide in food has not declined.

The presence of the carcinogenic acrylamide in food made headlines back in 2005. However, a Swedish study by the National Food Agency proves that eight years later the acrylamide level in food has not decreased. In some cases, levels exceeding the average level have even been measured, particularly in potato chips and wholemeal bread.

Consequently, industry should strive to reduce the level of acrylamide, particularly with a view to the forthcoming amendments. Industry is very responsive to this but calls for measures and steps on how to reduce the levels of acrylamide. This is the conclusion from the report, which can be found here (only in Swedish).

For more information on acrylamide, please contact

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

Lead released from espresso machines

High levels of lead have been measured in portafilter espresso machines, especially after descaling.

Although only a small number of samples were tested in a research project by BfR, the German Federal Institute for Risk Assessment, the results clearly showed release of lead from portafilter espresso machines. Levels were significantly higher compared to coffee pad and capsule machines. The culprit is believed to be lead-containing components or soldered connections. These results stress the importance of carrying out migration testing of machinery after the full intended descaling and rinsing cycle, since these procedures can give rise to increased release of lead.

Limit values
The release limit for lead is based on the permissible lead content in drinking water, as there is no limit value in the EU for the release of metals from metallic food contact materials. The European Council stipulates an upper limit of 10 µg/kg for the release of lead in food.

More information on limits for metals released from food contact materials can be found in the practical guide Metals and alloys used in food contact materials and articles published by the European Council.

For more information on food contact materials and testing of coffee machines, please contact

Eva Høy Engelund
ehe@dhigroup.com
Tel +45 4516 9096

Life science

International conference on alternatives to pthalates in medical devices

On 27 March the international conference Alternatives to Classified Phthalates in PVC Medical Devices will be held in Copenhagen.

The conference will focus on available alternative plasticisers to DEHP in medical devices. At the conference the Danish EPA will for the first time present the conclusions in a report, where ten different existing alternative plasticisers have been evaluated. Furthermore, all relevant aspects related to the latest development within the use of plasticised PVC in medical devices will be covered.

For more information on the conference and details on registration, please read here.

DHI has composed the report on the existing alternative plasticisers, which will be presented at the conference. For more information, please contact

Brian S. Nielsen
bsn@dhigroup.com
Tel +45 4516 9140

Finding new ways in risk assessment of chemical mixtures

German, French and Danish researches have joined forces to solve the challenges in risk assessment of chemical mixtures. Especially in occupational environments, a high level of exposure to chemical mixtures has been observed, but the exposure also comes from food, water, air and everyday consumer products.

Interdisciplinary approach
The common substance by substance approach to risk assessment is both questionable and inadequate when assessing the combined effects of chemicals. Consequently, new methods, new models, new databases and new biomarkers for risk assessment must be identified. Furthermore, an interdisciplinary approach is essential and must include experts in toxicology, biomathematics, epidemiology, social science, etc. Finally, research must be on a wide European level.

ANSES, the French health agency; BfR, the German Federal Institute for Risk Assessment, and the Danish National Food Institute (DTU) have established a cooperation to jointly tackle the challenges of assessing chemical mixtures.

For more information on chemicals and risk assessment, please contact

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

Nanoparticles as drug delivery carriers to the CNS

Delivery of pharmaceuticals to the central nervous system (CNS) is difficult due to the blood brain barrier, which limits the access. Nanoparticles could be a potential carrier, due to their unique properties, but the particles should not contribute to the effect nor cause side effects. In a Danish study, the toxicological effects of potential nano‐carriers to the central nervous system have been assessed.

Histological changes
Polymeric micelles (~50nm) and liposomes (~90nm) with either anionic or cationic properties were evaluated for their potential toxicity both systemically and locally in the brain. The passage across the blood brain barrier (BBB) was circumvented by injecting the particles directly into the ventricles of the brain. Here cationic particles, both micelles and liposomes, induced several histological changes in the CNS after injections. The changes were mainly on neurons in the granular cell layer in the dentate gyrus of the hippocampus, when compared to controls.

Neuronal cell death and immune system activation was observed, indicated by activated microglia and astrocytes, respectively. The toxicity observed could be due to the cationic effect, since no effects were seen with anionic particles or control buffer.

Changes were not detected in histology, hematology or clinical chemistry in peripheral tissues after intravenous injections. Thus only the brain tissue was affected by the particle toxicity.

Further reading
Further reading is possible in the articles Differential toxicological response to positively and negatively charged nanoparticles in the rat brain, published in Nanotoxicology, 2014 November, and Biodistribution of Rhodamine B fluorescence-labeled cationic nanoparticles in rats, published in J Nanopart Res, 2014, Jan 04.

The study, entitled Toxicological assessment of nanoparticles intended as drug delivery carriers for the CNS, was carried out in collaboration with DHI, H. Lundbeck and the University of Copenhagen.

For more information, please contact

Henrik Rye Lam
hrl@dhigroup.com


Meet us

8th International Fresenius Conference, Germany
Michael Fink has been invited to speak about How to deal with the Biocidal Products Regulation – requirements for formulators and professional users of disinfectants, at the Fresenius Conference on Detergents and Cleaning Products on 12 and 13 February 2014 in Mainz, Germany

ChemCon Europe 2014, Turkey
DHI participates at the International Conference on Chemical Control Legislation & Trade Aspects (ChemCon) which takes place on 31 March thru 4 April 2014 in Istanbul, Turkey.

SEPAWA Nordic, Sweden
Michael Fink has also been invited to give a presentation entitled Status of the new Biocidal Products Regulation and its impact on formulators at the SEPAWA Nordic conference in Sweden on 5 - 6 May. SEPAWA is an association of industry partners within the field of cosmetics, perfume, wash and detergent chemistry.

Courses

GHS Classification and labelling of chemicals - 5 and 6 March, Singapore
QSAR workshop – 7 May, Denmark
See our remaining courses (in Danish) on our website.

Contact

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



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