Chemicals and Regulatory Toxicology Newsletter

November 2016


ECHA discontinues pending Article 95 list

ECHA has decided to discontinue publication of the list of pending applications for inclusion in the Article 95 list.

Since the Article 95 list of approved active substances and suppliers became effective in September 2015, ECHA has regularly published a list of pending applications to the official Article 95. However, the pending list will no longer be published.

As of November 2016, the Article 95 list will be updated monthly and will only include newly approved applications, substances and suppliers.

For more information, please contact:

Michael Fink
Tel +45 4516 9156

New features in biocides submission tools

The two IT tools used for biocide submissions - R4BP 3 and SPC Editor – have been updated to support new possibilities for managing authorisations in the European Union. Consequently, the tools are now in line with the more flexible authorisation measures that came into force on 1 November.

Improved features for biocidal product families
One of the notable updates is that R4BP 3 now supports applications for identical (family or single) biocidal products from an already Union authorised product. Furthermore, applicants can request approval of a new product type in an already approved active substance, and a new member can be added to an authorisation product family.

The SPC Editor now supports the preparation of product families with three levels: family, meta and product. From product families, it is also possible to generate summaries for identical biocidal product applications.

For further details, check out the release note on R4BP 3 and SPC 2.0 .

For more information on the use of R4BP 3 and SPC Editor, please contact

Thit Aarøe Mørck
Tel +45 4516 9567

Consumer Safety

Phthalate substitutes in toys not a health risk

Four substances, which are substitutes for phthalates in toys, do not pose a risk to children’s health.

This conclusion is reached by ANSES, the French agency for food, environmental and occupational health and safety. An ANSES study comprising five phthalate substitutes had particular focus on children under the age of three, as oral exposure is an important exposure route for small children.

The following four phthalate substitutes did not cause concern:

  • 1,2-cyclohexane dicarboxylic acid diisonyl ester (DINCH)
  • diethylhexyl-terephthalate (DEHTP)
  • acetyl-tributyl-citrate (ATBC)
  • 2,2,4-trimethyl-1,3-pentanediol diisobutyrate (TXIB)

The fifth substitute, bis(2-ethylhexyl) isophthalate (DOIP), however, could not be assessed properly due to lack of available data. ANSES recommends that the substance is not used in toys or materials until it has been thoroughly assessed.

For further details, please read the ANSES opinion on Plastic toys and children's equipment intended for children under three years of age

For more information on toluene, please contact

Lise M. Møller
Tel +45 4516 9133

Health assessment of children’s carpets

Carpets may impact the indoor climate due to their large surfaces. As children are particularly vulnerable to chemicals, the Danish Environmental Protection Agency has examined whether chemical substances in children’s carpets can have adverse health effects.

In the project three groups of chemicals were examined: volatile organic compounds (VOC), phthalates and per- and polyfluoroalkyl substances (PFAS). Several substances within these three groups are on the Candidate List of substances of very high concern (SVHC) and the Danish list of undesirable substances (LOUS). The survey does not include dyes and flame retardants, and consequently it is not a comprehensive study of substances in children’s carpets.

No concern for adverse health effects
A random sample was carried out of 21 children’s carpets. Contents of problematic substances was found in several carpets but not in amounts that gave rise to alarm. Overall, the use of carpets in the child’s room is not of concern with regard to adverse health effects even if some of the substances in the carpets can emit unpleasant smells.

The survey is part of the Danish EPA’s ongoing survey of chemical substances in consumer products. The survey was carried out by DHI (health risk assessment) in collaboration with the Danish Technological Institute. Unfortunately, the report is not yet available in English, only in Danish.

For more information, please consult

Poul Bo Larsen
Tel +45 4516 9478

Cosmetic ingredients above 1 tonne must be registered in the EU

Ingredients used in cosmetics are chemical substances or mixtures of chemical substances. Accordingly, chemical substances or mixtures used in cosmetics and health care products marketed in the European Union must fulfil the requirements of the EU REACH Regulation concerning registration of chemical substances.

Manufacturers of cosmetics and health care products must pay attention to the deadline of 31 May 2018 in the REACH Regulation concerning registration of chemical substances above 1 tonne imported from countries outside of the EU. If substances are not registered by 31 May 2018, the products must no longer be on the EU market.

It is time-consuming to get access to registration data and to register substances with the Euro­pean Chemicals Agency, ECHA. Consequently, you should start the process now in order to meet the 2018 deadline.

Calculating the 1 tonne limit
Calculating the 1 tonne limit for registration of a substance should be done as an average of the import over the previous three years. The amount of 1 tonne includes the total amount of the substance imported, in other words both pure substances and substances that are part of mixtures in raw materials or finished products. If you buy 5 tonnes conditioner from China containing 11% glycerine and 5 tonnes hand lotion containing 15% glycerine, then the amount of imported glycerine totals 1.3 tonnes. This means that glycerine must be registered.

The 2018 deadline is only valid for companies that have already preregistered a chemical substance. If you import more than 1 tonne yearly of a substance that has not been preregistered, the substance must be registered immediately.

For more information on cosmetics and registration of substances, please contact

Lise M. Møller
Tel  +45 4516 9133


Nickel migration to be regulated in plastic for food contact

The EU Commission has issued a hearing procedure on the draft amendment of the plastic food contact material regulation (10/2011). One of the more interesting proposals is that nickel will be limited to 0.02 mg/kg food or food simulant. This is a result of the European Food Safety Authority’s (EFSA) opinion on the risks to public health related to the presence of nickel (Ni) in food and drinking water.

Nickel exposure above TDI
The EFSA opinion establishes a tolerable daily intake (TDI) of 2.8 μg Ni per kg body weight per day. EFSA indicates that the mean chronic dietary exposure to Ni is above the TDI, particularly when considering the young population. Consequently, it is appropriate to apply an allocation factor of 10% to the conventionally derived migration limit, resulting in a migration limit of 0.02 mg/kg food for migration of Ni from plastic food contact materials.

Link to the hearing (in Danish, but two of the accompanying documents are in English) here.

For more information on migration limits and food contact materials, please consult

Helle Buchardt Boyd
Tel +45 4516 9097 

Petition on mineral oil residues in food

The non-profit organisation Foodwatch has handed over more than 100,000 signatures to the European Commissioner for Health and Food Safety calling for action against mineral oil residues in food.

The three main points of the petition is

  • EU-wide limit values for mineral oil saturated hydrocarbons (MOSH) in food
  • EU-wide zero-tolerance for mineral oil aromatic hydrocarbons (MOAH) in food
  • Mandatory requirement of functional barriers in (recycled) paper and board food packaging to prevent mineral oil from migrating into food

Recent German findings of MOSH and MOAH include premium chocolate and several brands of doughnuts.

For more information, please contact

Helle Buchardt Boyd
Tel +45 4516 9097 

Life science

OECD guidance on testing and assessment of skin sensitisation

The OECD has published new guidance documents on Integrated Approaches to Testing and Assessment (IATA).

The first guidance concerns principles for reporting of defined approaches within IATA, including a number of associated templates. The second guidance illustrates how the templates can be used to document defined approaches in the area of skin sensitisation, exemplified via case studies for skin sensitisation.

  1. Guidance Document on the Reporting of Defined Approaches to be Used within Integrated Approaches to Testing and Assessment
  2. Guidance Document on the Reporting of Defined Approaches and Individual Information Sources to be Used within Integrated Approaches to Testing and Assessment (IATA) for Skin Sensitisation, including Annex 1 and Annex 2

    Annex 1 of this guidance includes 12 case studies for skin sensitisation. They are examples of the level of information needed to facilitate a harmonised approach to the reporting of defined approaches.

IATA are science-based approaches for chemical hazard identification, characterisation and/or safety assessments using multiple information sources. This includes integration of existing information with new methodological approaches such as QSAR, read-across, in vitro, in chemico, omic technologies etc.

For more information on skin sensitisation and testing, please contact

Brian S. Nielsen
Tel +45 4516 9140

FDA guidance on ISO 10993 and biological evaluation of medical devices

The US Food and Drug Administration (FDA) has updated their guidance document for industry on biological evaluation of medical devices according to the ISO 10993-1 standard. The guidance replaces an almost 20-year-old guidance and incorporates several new considerations, including the use of risk-based approaches to determine if biocompatibility testing is needed.

Recommendations for submicron, nano and in situ materials
The guidance also includes chemical assessment recommendations, and recommendations for biocompatibility test preparations for devices with submicron or nanotechnology components and for devices made from in situ polymerizing and/or absorbable materials.

Concerning the risk-based approach to biocompatibility, it is recommended that risk assessments should include not only the finished material but also device materials, processing parameters and manufacturing methods. Furthermore, when conducting risk assessments manufacturers should thoroughly screen for any available risk information and data to avoid unnecessary testing.

For full details, please view the FDA guidance on Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

For more information on approval of medical devices, please contact

Brian S. Nielsen
Tel +45 4516 9140


Easier use of biological pesticides in Sweden

Swedish authorities will implement a new approval scheme for nematodes, insects and mites as biological plant protection products or biocides in 2017.

You must apply for approval with the Swedish Environmental Protection Agency. What is new is that the animal species and not the product must be approved. The Swedish EPA will prepare applications and evaluations of animal species already on the EPPO list (European and Mediterranean Plant Protection Organization).

More information and a list of the first 28 approved animals will be available on the Swedish EPA’s website in early 2017. A list of all approved animals is expected in the autumn of 2017.

For more information, please contact

Ann Detmer
Tel +45 4516 9103

Metal-based nanoparticles in aquatic environments

Little is known about how engineered nanoparticles pass through aquatic food webs, even though the behaviour of nanoparticles in organisms that constitute foods items is highly important.

A research review has investigated the transfer of metal-containing engineered nanoparticles (Me-ENPs) in aquatic environments. The Me-ENPs have been shown to be taken up by different species but how the particles pass through aquatic food webs, also known as trophic transfer, is poorly understood.

The review has identified four key factors affecting the trophic transfer of Me-ENPs and particularly two factors require more research. These two factors are the internal fate of Me-ENPs in prey organisms and the impact of the predator’s digestive physiology. In addition, the review suggests that it is likely that the Me-ENPs association to sediment is a key process in transfer of the particles within the aquatic food web.

The review Trophic transfer of metal-based nanoparticles in aquatic environments: a review and recommendations for future research focus is published in Environmental Science: Nano, 5, 2016.

The review is funded in part by DHI and carried out in collaboration with Roskilde University in Denmark.

For more information, please contact

Margrethe Winther-Nielsen
Tel +45 4516 9320

Meet us at

European Symposium on The New Agreed Draft Regulations on Medical Devices (RMD2016) - Czech Republic
Scientific Adviser Torben W. Schou participated in the above symposium in Prague on 7-8 November.

Extractables and Leachables Europe 2016 - Ireland
Senior Toxicologist Helle Buchardt Boyd presented a poster on Addressing Consumer Concerns Regarding Leachables. The conference took place in Dublin on 8-10 November.

The DoC for Food Contact Materials: New Challenges Ahead - Brussels
Senior Adviser Eva Høy Engelund has been invited to speak at this seminar, which will discuss the requirements of the Declaration of Compliance (DoC) for Food Contact Materials.  The seminar is hosted by Steptoe in Brussels on 6 December.


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