Newsletter on Chemicals and Regulatory Toxicology

December 2018


EDC criteria for PPPs and thyroid mediated effects

The criteria for determination of endocrine disrupting properties have now started to kick in for plant protection products (PPP).

As of 10 November 2018 new criteria came in force concerning applications for renewal of approval of active substances in accordance with EU Regulation (EC) No 1107/2009. This is the result of the European Commission’s recent release of the Implementing Regulation (EU) 2018/1659 concerning scientific criteria for determination of endocrine disrupting properties.

Several challenges for identification of possible endocrine disrupting substances are related to the difficulties of documenting thyroid mediated adversity and activity.

DHI has highly skilled toxicologists who can assist you in assembling the lines of evidence. We will support you in gathering, evaluating and putting together relevant information to ascertain if the endocrine disrupting criteria are fulfilled.

For further information, please contact:

Thit Aarøe Mørck
Tel +45 4516 9567

New REACH annexes on substance nanoforms

On 3 December the European Commission adopted a number of amended REACH annexes addressing substances on nanoform. The regulation will apply from 2020.

The amended annexes specify the information required for the nanoform of a registered substance. This includes physico-chemical properties and conditions to consider when carrying out toxicological or ecotoxicological tests. To enhance the efficiency of registrations it is possible to group nanoforms or sets of nanoforms with similar characteristics when the grouping can be substantiated. Similarities in the molecular structure, however, cannot serve as justification for the application of grouping.

All dossiers with nanoforms to be updated
The amended REACH annexes will apply from 1 January 2020. As of this date, also previous registrants of substances that include nanoforms must update their dossiers in accordance with the new requirements.

View the draft regulation on REACH annexes addressing nanoforms of substances

For more information about registration of nanomaterials, please contact

Margrethe Winther-Nielsen
Tel +45 4516 9320

Christmas lights contain harmful chemicals

Right now Christmas lights light up streets and shopping malls in many parts of the world and few people associate the lights with harmful substances. Even so, in a random check the Swedish Chemicals Agency, KEMI, found that the content of harmful substances in Christmas lights and also electrical decorations and electrical products for personal care exceeded the limit value in 14 out of 96 samples.

The substances included lead, cadmium, short-chain chlorinated paraffins (SCCPs), phthalates and the flame retardant HBCDD. Furthermore, six products contained SVHC substances (DEHP and DBP) on the REACH Candidate List in amounts exceeding 0.1%.

So far KEMI’s full report on Christmas lights is only available in Swedish (with a short English summary on page 7).

KEMI’s advice to businesses that import Christmas lights and electrical products is to demand precise information on the chemical content from their product suppliers.

For more information or advice on harmful substances, please contact:

Lise M. Møller
Tel +45 4516 9133

Change in Danish workplace instructions on hazardous chemicals

For nearly 40 years, workplace instructions have been mandatory in Denmark when working with hazardous chemicals and materials. The instructions are expected to be abolished before long.

According to a public hearing launched by the Danish Working Environment Authority, written workplace instructions on hazardous chemicals and materials will be abolished. Instead focus will be on the employer’s obligation to ensure the necessary instructions on working with hazardous chemicals and materials. Furthermore, the compulsory workplace assessment on chemical risks in connection with hazardous chemicals and materials must be in writing.

The new regulation is expected to become effective on 1 July 2019.

For more information, please contact:

Helle M. Andersen
Tel +45 4516 9023

Mapping of DIY products

The use of do-it-yourself (DIY) products is not without risks and it is important to use protective equipment.

This is the conclusion of a mapping project of chemical DIY products on the Danish market for which we have carried out the risk assessment. The study included floor lacquers and floor paint, PU sealing foams and wet room paint; all typical DIY products used when renovating floors or bathrooms. The products were for sale through DIY centres or on websites.

Product risks
Information was collected for a total of 54 products containing 96 substances with a hazard classification. Nine products were selected for further risk assessment based on knowledge of the substance content and degassing was measured during work. The risk assessment showed that eight of the nine products posed a risk if the user did not use personal protective equipment such as protective gloves or respiratory protective equipment.

The identified substances include substances that are eye and respiratory irritants or may cause reproductive effects, increased cancer risk or chronic neurotoxic effects. None of the identified substances are included on the EU REACH’s Candidate List (SVHC substances).

Prolonged evaporation
Not only does the use of the products pose a risk. It may take more than a month before floor paint and floor lacquers have evaporated. Consequently, ample venting of the rooms is required after application.

A summary and conclusions of the report in English is available here (page 12-17). The project was carried out on behalf of the Danish Environmental Protection Agency in collaboration with the consultants COWI and the Danish Technological Institute.

For more information about the project or about DIY products, please contact:

Poul Bo Larsen
Tel +45 4516 9478

Transport of dangerous goods

RID 2019 now available

The amended edition of the European regulation governing the transport of dangerous goods by rail (RID) is available for download here.

If you did not read our post in the November newsletter about some of the significant changes in the updated RID and ADR (transport of dangerous goods by road), you can still read it here.

Compliance with RID 2019 and ADR 2019 is optional from 1 January 2019 and mandatory as of 1 July 2019.

For more advice on transport of dangerous goods, please contact:

Ingelise Dige Semark
Tel +45 4516 9221

Life Science

SCCS guidance gives priority to non-animal test methods

Non-animal test methods have been given priority in the 10th revision of the Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation from the EU Scientific Committee on Consumer Safety, SCCS. In addition, an update on non-animal toxicological studies for cosmetic ingredients has been included.

In the guidance it is recommended to use a combination of in chemico (grouping and other chemical analogy approaches) and in silico simulated data (such as QSAR modeling or read-across) to predict and assess the toxicity of cosmetic ingredients before any in vitro testing is considered.

Prediction models are gaining ground
Besides the EU Cosmetic Regulation, other regulations worldwide have implemented the use of toxicological prediction models for safety documentation. These include regulatory requirements set by the European Chemicals Agency (ECHA), the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) as well as the European Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). Some regulations even accept the alternatives as a first-tier approach.

As an example, the new ICH M7 guideline on assessment of impurities in pharmaceuticals describes how the toxicological profile is supported by using in silico simulated data to identify DNA reactive, mutagenic impurities to limit possible carcinogenic risks.

When and why to use prediction models?
You can benefit from using prediction models:

  • When limited or no data is available.
  • To save cost on testing. The price of a prediction is significantly less than that of a traditional laboratory in vitro test

In vivo testing is no longer permitted under the EU cosmetic regulation but still an option in other regulations.

DHI offers a range of computational models and strategies as an alternative to traditional laboratory tests. In chemico and in silico models such as QSAR and read-across are valuable tools to predict chemically induced toxicity when limited or no toxicological data is available. QSAR is also a fast and cheap way to generate data and fill data gaps.

We have a long track record of using different QSAR models in combination with read-across and grouping of chemicals when it comes to help clients perform product safety assessments in compliance with the regulatory requirements and guidance.

For more information and guidance on alternative test methods, please contact:

Brian Svend Nielsen
Tel +45 4516 9140

Daniel Vest Christophersen
Tel +45 4516 9469


Dioxins and PCBs still a health concern

In spite of a decline in the presence of dioxins and dioxin-like PCBs in the last 30 years and newly established levels for tolerable intake, the substances are still a health concern.

New tolerable intake
This year the European Food Safety Authority, EFSA, has made a thorough review of the risks to humans from dioxins and PCBs in food and has set a new tolerable weekly intake (TWI) for dioxins and PCBs in food at 2 picograms per kg body weight. The new TWI is a significant lowering of the previous tolerable level at 14 pg per kg body weight, but all age groups of the European population is still exposed to a weekly intake of dioxins or PCBs that is up to 15 times the new TWI.

The main contributors to dietary exposure are fatty fish, cheese and meat. Dioxins and PCBs may have effects on the semen quality, hormones and enamel defects on teeth.

For advice on substances in food, please contact:

Helle Buchardt Boyd
Tel +45 4516 9097

Free Webinar

A supply chain without problematic chemistry in a circular economy

A transparent supply chain is one of the keys to avoiding problematic chemical substances in your products.In this free webinar on 18 December you will hear about a printing company which has been through the process of substituting problematic substances in their entire product portfolio. Furthermore, we will introduce a new guidance and tools supporting companies towards a circular economy.

Read more and sign up here


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