Chemicals and Regulatory Toxicology Newsletter

December 2016




Biocides

Discrepancies in interpretation of EU biocidal rules

A survey on articles treated with biocides has been conducted by the Swedish Chemicals Agency (KEMI) and reveals a need for better guidance on the European Biocidal Products Regulation (BPR).

The focus of the survey was on biocide treated articles available to consumers and disclosed several areas for improvement. Nine countries were asked to categorise ten products and only agreed on the categorisation of one product. This emphasises that it is too complicated to interpret the borderline between biocidal products and treated articles and calls for clearer rules and better guidelines.

Noncompliance of labelling requirements
The survey also exposed non-fulfilment of labelling requirements for the majority of articles. Only in very few cases did the products contain information on the active substances, and the products lacked instructions for use or information on precautionary measures. Moreover, a great number of products contain biocides without claiming it (silent treatment) which shows that there are more treated articles on the market than those claiming to be treated.

According to the BPR, manufacturers and suppliers are obliged to reply upon request within 45 days with information about the content of active substances. However, many actors on the market are not aware of this and better information on the requirements is needed.

For further details, please review KEMI’s report on Market survey on articles treated with biocides.

For information on biocidal regulation and articles, please contact:

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


Biocides consortia for product authorisation

Working together in consortia to achieve authorisation of individual biocidal products can save costs, resources and time for both producers, manufacturers and importers of biocidal products.

The European Biocidal Products Regulation allows consortia to be formed for product authorisations and can prove to be an excellent solution for SMEs within biocides. Consortia exploit the benefits of authorising biocidal product families with subsequent authorisation of own products made by the individual members through the regulation specifying a procedure for the authorisation of same biocidal products. In this way, consortia members share the most costly parts of the authorisation while individual product authorisations are maintained independently.

DHI to form consortium in early 2017
DHI acts as authorisation holder, facilitator or third party for handling of confidential information and management of consortia. We intend to set up the first consortium in the 1st quarter of 2017. More information on the specific active substances and products will follow.

If you are interested in more information, please contact

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


Life science

Safety is key issue in update of EU medical device regulations

Much higher requirements for documentation of risk assessment of hazardous substances in medical devices can be expected with implementation of the newly agreed draft regulations on medical devices.

This was one of the main messages at the first European Symposium on The New Agreed Draft Regulations on Medical Devices (RMD2016), which was held in November in Prague, Czech Republic.

Documentation for assessment of hazardous substances to be tightened
The aim of the symposium was to address and discuss important updates in the newly drafted Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The new regulations are expected to apply from 2019 (medical devices) and 2021 (in vitro diagnostics), respectively. Since safety is a key issue in the new MDR and IVDR, the regulations are much more detailed concerning general safety and performance requirements. As a result, the amount of documentation needed for risk assessment of hazardous substances in devices is expected to increase significantly.

At present some uncertainty remains about the application of the new regulations. Therefore, it is important that manufacturers keep updated and aware of any additional changes that may affect them.

More in-depth details are available on the European Council's webpage, including pdf’s of the new MDR and IVDR.

For more information on risk assessment of hazardous substances and safety evaluation of medical devices, please contact:

Torben W. Schou
tws@dhigroup.com
Tel +45 4516 9504


DHI project to reduce packaging waste

DHI is to develop a method that will help the packaging industry to design products and select materials without substances of concern. The object is to improve recycling of materials, reduce packaging waste and support a circular economy.

The method will consider environment and human health in parallel with technical functionality of the packaging. We will anchor metrics for environment and human health in international recognised models for analysis and optimisation of global supply chains. In addition, the packaging must comply with regulatory requirements and fulfil international standards. The project is aimed at manufacturers, importers, suppliers and users of packaging. The project principles, however, will also be applicable in other industries.

The project is carried out in connection with a Danish national strategy for waste prevention and is supported by the Danish Agency for Science, Technology and Innovation. The project will be completed in 2018.

For more information, please contact

Margrethe Winther-Nielsen
mwn@dhigroup.com
Tel +45 4516 9320


Food

EU harmonisation of food contact materials regulation

The European Parliament has passed a resolution on increased harmonisation of the food contact materials regulation. If the resolution is endorsed, then European food businesses must document that all food contact materials comply with regulations. This procedure has been compulsory in Denmark for quite some years, but the introduction of mandatory declarations of compliance (DoC) for all materials in contact with food will be a new practise to most European countries.

The European Parliament has passed the resolution with a view to protect consumers from hazardous chemicals from food contact materials and to harmonise the EU requirements for the food industry.

In early December, the law firm Steptoe in Brussles invited DHI to give a talk on the Danish experience with DoCs for food contact materials at the seminar The DoC for Food Contact Materials: New Challenges Ahead.

For more information, please contact

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


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