News about Environment
and Toxicology

February 2016


REACH Implementing Regulation in force

As of 27 January 2016, the European Commission strengthens the principle of one substance – one registration by a so-called Implementing Regulation. This empowers ECHA to ensure that all registrants of the same substance are part of the same registration under REACH.

In future, only one joint registration can be created for each registration type: full registration and registration of an intermediate substance. It is still possible under a joint registration to opt-out from data sharing fully or partly, but this is to be communicated to the other registrants and to ECHA. Existing individual submissions will eventually be included in a joint registration.

Fairness in data and cost sharing
An important part of the regulation concerns transparency and fair data sharing. In future, registrants are required to itemise and justify the cost of the different studies in order to set a fair and transparent price on a Letter of Access (LoA). Furthermore, cost sharing models used by the SIEF should contain a reimbursement mechanism to prevent data sharing from becoming a money machine for data holders.

For more information on the Implementing Regulation, please contact

Jens Tørsløv
Tel +45 4516 9022

Substances of concern

DHI has prepared a guidance for companies that use substances of concern in their production, including substances of very high concern (SVHC) on the Candidate List under the EU REACH Regulation. The guidance is a tool for identifying substances of concern and a help to make the right decisions.

Substances of very high concern in REACH include substances that are carcinogenic, mutagenic or toxic to reproduction or may cause long-lasting effects to organisms in the environment.

Phase-out or substitution
If your production includes substances of concern, the preferred solution is to either phase out or substitute the substances. To apply for authorisation for use under REACH should only be considered when a phase-out or substitution is not possible.

The guidance is available in Danish as it is part of a research project funded by The Danish Ministry
of Higher Education and Science.

For more information on substances of concern and the guidance, please contact:

Anne Rathmann Pedersen
Tel +45 4516 9370

Meet us at ChemCon Europe 2016

Will you also attend ChemCon in Amsterdam on 15-18 March? If yes, we hope you will drop by our stand for an informal chat with our conference delegates.

At our stand we welcome you to:

  • Try our free GHS Portal
  • Get an introduction to our new exposure scenario tool for mixtures: ES Creator
  • Discuss biocidal regulation and dossiers with our regulatory experts
  • Learn about our services for ecotoxicological testing of chemicals

We look forward to meeting you at ChemCon Europe 2016.

Free webinar: Danish code numbers

In Denmark paint, glues, adhesives, fillers, printing ink, thinners etc. must carry a special code number (also known as a MAL code).

Join our free webinar if you want an overview of the Danish rules, including which products are covered, required information to calculate a code number, and what the code numbers mean in practice. Please note that the webinar will not deal with calculation of code numbers.

Target group: The webinar is in English. It addresses both Danish and international manufacturers, suppliers and importers of chemicals for professional use in Denmark.

Date: Tuesday 15 March at 3 pm – 3.45 pm (Danish time, UTC +1)

Sign up: If you want to join the webinar, please send an e-mail to Vibeke Salmon:


April deadline for notification of in situ generated active substances

The EU deadline for notification of in situ generated substances is 27 April 2016. This deadline also includes alternative precursors generating the in situ generated active substance.

Be aware, that active substances originally defined as an active substance on its own may now be covered by the definition of an in situ generated substance, even though it is used on its own and without being generated in situ.
View ECHA’s list of In situ active substance/precursor-combination open for notification

For more information, you are also welcome to contact:

Michael Fink
Tel +45 4516 9156

Four biocidal actives non-approved

As of 16 February 2016 four biocidal actives are no longer approved for use in the European Union for the following product-types (PT):

  • triclosan (PT1)
  • polyhexamethylene biguanide (PHMB), for use in human hygiene disinfectants (PT1), preservatives for products during storage (PT6), and fibre, leather, rubber and polymerised materials preservatives (PT9)
  • 2-butanone (PT1) and disinfectants or algaecides not intended for direct application to humans or animals (PT2)
  • cybutryne, for use in antifouling products (PT21)

For more information on biocides and actives, please contact:

Michael Fink
Tel +45 4516 9156

Illegal pest control products in Denmark

In 2016 the Danish EPA will strengthen its control of retailers and importers of pest control biocides and pesticides. During recent inspections, almost half the inspections were non-compliant with the legislation and three companies were reported to the police.

It is the responsibility of the importers and retailers that products on the market are approved for use and are stored correctly. This includes pest control products for both professional and private users.

For more information on biocides and pesticides, please contact

Kirsten Bogtoft Møller
Tel +45 4516 9054


Impurities in food contact materials

Would you sign a declaration confirming that there are no impurities in your food contact material? Many manufacturers of food contact materials have met such a demand. However, when the demand includes impurities from substances not intentionally added during the process, it can be quite tricky to know what you are signing.

The substances are known as non-intentionally added substances (NIAS). Consequently, they are not residues of monomers, additives, catalysts, solvents, etc. intentionally added to the process with a specific purpose. Non-intentionally added substances are other substances that may be found in a product.

Same product – different impurity profiles
Above all, to avoid impurities in food contact materials you have to know the quality of your raw materials and your production processes well. Furthermore, impurities will always occur that are specific for the individual production sites. In other words, the same type of material produced at two different sites will have different impurity profiles.

The subject of non-intentionally added substances was a hot issue at the PIRA Conference on food contact materials in Barcelona at the end of 2015. If you want to know more, please contact:

Eva Høy Engelund
Tel +45 4516 9096

Do not overheat food in microwave ovens

The French Agency, ANSES, has examined different types of microwave food packaging under three types of heating conditions (heating according to the manufacturer’s recommendations, ambient temperature and extreme heating). Even at ambient temperatures, the study revealed the presence of substances used as lubricants in several samples.

Based on the study, the researchers recommend

  • to avoid extreme reheating
  • to follow the manufacturer’s recommendations on power level and cooking time
  • to choose longer time instead of higher power level, if the original recommendations do not provide a satisfactorily heated food item

The study was mentioned here.

For more information on food packaging materials, please contact:

Helle Buchardt Boyd
Tel +45 4516 9097

Public consultations in EFSA

The European Food Safety Authority (EFSA) has published a forecast of upcoming consultations in 2016. Interested stakeholders are encouraged to submit data or assessments when the consultations are open for comments.

View the EFSA public consultation forecast.

We find the following consultations of particular interest:

  • vitamin D (18 January)
  • choline, vitamin B6 (25 January)
  • sodium, potassium and chloride (18 July)
  • vitamin K (22 July)
  • thiamin (10 October) as well as
  • exposure assessment of food enzymes (10 March)

For more information on the above or about food safety, please contact:

Helle Buchardt Boyd
Tel +45 4516 9097

Risk thermometer – a new tool for risk communication

The Swedish National Food Agency has developed a new tool for the food industry for comparing and communicating chemical risks associated with food consumption. The risk thermometer illustrates the health risk level when you are exposed to a chemical for a long time.

Below an illustration of the exposure risk to children to dioxins and PCB from food.

For more illustrations, please visit the Swedish National Food Agency’s website (in Swedish). It is possible to download a report in English, Report on Public Consultation, about the risk thermometer.

Furthermore, a more elaborate tool for professional use is available based on the severity-adjusted margin of exposure (SAMOE) methodology that has been used to assess the five risk stages of the risk thermometer.

For more information on food risk assessments, please contact

Ann Detmer
Tel +45 4516 9103

Meet us

Global Business Summit 2016, Brussels
Jens Tørsløv participates in this three-day summit focusing on the business implications of REACH and global supply chain issues. The conference is organised by Chemical Watch andtakes place on 23-25 February in Brussels.

ChemCon Europe 2016, Amsterdam
Meet our delegation on 15-18 March in Amsterdam, the Netherlands, when we participate in one of the most important regulatory conferences this year. We look forward to seeing you at our stand for an informal chat.


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