News about Environment
and Toxicology

June 2016




Chemicals

Guide on safe use information for mixtures under REACH

Most chemical substances are used with other substances in mixtures. If you are a supplier of a classified mixture of substances, a safety data sheet must be provided together with information on the safe use of the mixture. The information of safe use is to be derived from the exposure scenarios that you receive from the suppliers of the mixture ingredients.

Lead Component Identification
For this purpose, Cefic (The European Chemical Industry Council) and VCI (Verband der Chemischen Industrie) as representatives of the European chemicals industry have teamed up to develop a method on safe use of mixtures and are now ready with a guide. The method, called the Lead Component Identification (LCID) Methodology, was presented recently at a workshop in Brussels in which we participated.

Link to the REACH Practical Guide on Safe Use Information for Mixtures under REACH

You are also welcome to contact our workshop participants for more information:

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

Dorte Rasmussen
dor@dhigroup.com
Tel +45 4516 9316


Downstream user safety report of non-registered uses

Acids are used for many different purposes. Due to the very diverse use pattern of a specific acid not all the uses were identified and included in the registration dossier. Using a substance for purposes not covered by the registration is illegal, and in such cases it is the responsibility of the downstream user to act.

For this purpose, we assisted chemical distributors Brenntag Nordic in developing a Downstream User Chemical Safety Report (DU CSR) for a specific non-registered use of the acid. The specific use was reported to ECHA, and the relevant exposure scenarios and documentation were placed with the downstream user as documentation of compliance.

Easy solution when using different suppliers
Developing a DU CSR takes only a few working days and provides the downstream user with documentation of safe use and REACH compliance. The solution is an easy and fast alternative to getting the use included in the manufacturer’s registration. Moreover, the DU CSR allows the downstream user to use different suppliers without considering if their registration covers the use in question.

For more information, please contact

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


Registration of chemicals outside the EU

Being based in the European Union, DHI are of course fully versed in the requirements of the EU REACH Regulation. However, as many of our clients do business outside of the EU, we have considerable regulatory experience with other markets. Below an outline of the regulation concerning registration of chemicals in some major markets that we are also familiar with.

USA: In the US, new chemical substances must be notified in accordance with the US Toxic Substances Control Act (TSCA) section 12(b) that was updated recently. A notification requires detailed documentation of the substance identity and an agreement with the Chemicals Abstract Service (CAS) in order to obtain a correct CAS name and number. In addition, all existing toxicological information need to be collected and used as basis. To prepare and submit a registration dossier, you must use the e-CDX software provided by the US Environmental Protection Agency.

Canada: New substances must be notified according to the New Substances Notification (NSN) Regulations. A registration requires evaluation of toxicological and ecotoxicological data, including identification of data gaps. We have successfully used QSAR modelling to bridge such data-gaps for a notification that was accepted by the Canadian authorities.

Republic of Korea: A new chemicals regulation came into force on 1 January 2015. It is also known as K-REACH as it contains many of the same elements as the European REACH regulation. Manufacture and import above one tonne per year of all new and existing substances must be reported on a yearly basis. In addition, specific substances (currently 518) are designated for registration and need to be jointly registered before June 2018 by the manufacturing and importing companies of the same substance. The information requirements are similar to - but not the same - as those applied in the European REACH Regulation. DHI provides Only Representative services for non-Korean companies through a formal cooperation with the Korea Institute of Science and Technology (KIST) and Korea Institute of Industrial Technology (KITECH).

Switzerland: Switzerland is not a member of the EU or the European Economic Area (EEA). All new substances must be notified, registered and/or declared in Switzerland before they are placed on the market, even if they are already registered in the EU under REACH. Substances has to be registered according to the Swiss Ordinance on Protection against Dangerous Substances and Preparations (Chemicals Ordinance; ChemO, SR 813.11, 4th Revision (i.e. ChemO).

Russia: Before manufacturing/importing a substance in the Russian Federation, the manufacturer or importer has to comply with the requirements of the Russian Register of Potentially Hazardous Chemical and Biological Substances (Rospotrebnadzor). Notification requires a broad range of toxicological and ecotoxicological information. Russian authorities consider the information requirements as well as the dossier evaluation on a case-by-case basis. Rospotrebnadzo requires that a substance is registered for a certain term, usually 3 years. Upon expiry of the term, the registration procedure must be renewed.

Core dataset for worldwide registration
In general, the data requirements for registration of chemical substances across the industrialised countries tend to be similar. Consequently, a strategic company approach to global registration should include establishment of a core dataset for use in different registration regimes. A key issue is to obtain the legal right to use shared data. Normally a letter of access to a European REACH registration does not allow use of data for registration outside of the EU. In some cases, the cost of buying such rights might be higher than performing tests at GLP certified/OECD MAD (Mutual Acceptance of Data) compliant labs, for example in the Republic of Korea.

For more information on registration of chemicals, please contact

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


Free webinar: REACH 2018 and obligations for small and medium sized industries

Many small and medium sized industries may be unaware of their obligations to register chemical substances in the EU. The deadline for pre-registered substances imported or manufactured in the tonnage range from 1–100 tonnes per year is 1 June 2018. Join our free webinar and learn more about the steps you need to take in order to comply with REACH.

Target group: The webinar addresses manufacturers and importers of chemical products that have no previous experience with REACH registrations. The webinar is also relevant for non-European exporters of chemicals to the EU that are not familiar with the REACH requirements.

Date: Monday 27 June at 3 pm – 3:45 pm (Danish time, UTC +1)

The webinar will also be offered in Danish on 30 August 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: ves@dhigroup.com


IUCLID 6 courses in September

At DHI we are experienced users of IUCLID and have successfully submitted many registration dossiers for industry clients. In September, we host two courses in IUCLID 6 that will give you hands-on experience with the latest version of the IUCLID tool:

At both courses you will receive expert advice on how to use IUCLID 6 for your dossiers, and we will guide you through the process of creating a dossier step-by-step.

If interested, you can register for the courses on our Academy website.

For more information on IUCLID, please contact

Hülya Genc Fuhrman
hgf@dhigroup.com
Tel +45 4516 9256


Biocides

Benefits of consortia for product authorisation

The process of obtaining a biocidal product authorisation can be demanding in terms of resources and fees. However, costs can be saved by forming industry consortia for specific product formulations. By joining a consortium, the main benefits are the cost sharing of

  • authority fees
  • test fees
  • fees for generating technical dossier in IUCLID, and
  • fees related to creating the product assessment report (PAR)

This route of approval can be of interest to companies that place biocidal products containing permethrin + PBO, ethanol, hydrogen peroxide, sodium hypochlorite, peracetic acid and others on the market.

If you want to know more about consortia within the biocides regime, please contact

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


Use IUCLID 6 from 5 July for biocide dossiers

The new and updated version of IUCLID, version 6, has been released and can now be used to create biocide dossiers.

To ensure compatibility with IUCLID 6, the dossier submission tool R4BP 3 is also being updated. It is important to note that after the update of R4BP 3, which is planned for 5 July, all dossiers must be created in IUCLID 6 to be accepted by R4BP 3. It is possible to migrate dossiers created in IUCLID 5 to IUCLID 6. For more details, see here.

If you plan to submit a dossier after 5 July, you can install the IUCLID 6 now to avoid migration.

For further information, please contact

Thit Aarøe Mørck
tam@dhigroup.com
Tel +45 4516 9567


Life science

New rules for skin testing

Annexes VII and VIII of the REACH regulation concerning skin sensitisation and skin corrosion/irritation tests will be amended before long.

According to proposed amendments, in-vivo tests will be replaced by in vitro or in chemico methods for testing of chemical substances for skin corrosion/irritation, serious eye damage/eye irritation and acute toxicity and for skin sensitisation. In vitro and in chemico methods both address the biological and chemical mechanisms of skin sensitisation. The new rules are expected to become applicable by early autumn 2016.

addressing the biological and chemical mechanisms of skin sensitisation

View the proposed amendments here:

With the amendments in force, the amount of animal tests needed for the REACH registration deadline in 2018 will be significantly reduced.

For questions about testing, please contact

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


New ISO standards for medical devices - inhalation equipment

A new ISO draft guideline - ISO/DIS 18562 Biocompatibility evaluation of breathing gas pathways in healthcare applications - is available and open for public comments.

The current draft standard contains the following four parts:

The draft standards were prepared by a Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment.

Additional parts are proposed in relation to emissions of inorganic gases; compatibility with inhalational anaesthetic agents, and compatibility with inhalational therapeutics. However, these have not been published yet.

The new draft standards give a detailed overview of the requirements for safety evaluation of inhalation equipment - an area that have only been covered in much more general terms by the requirement described in ISO-10993-1: 2009 on Biological evaluation of medical devices.

For further information, please contact:

Poul Bo Larsen
pbl@dhigroup.com
Tel +45 4516 9478


Food

EU urged to harmonise legislation on food contact materials

In a draft motion for resolution from the EU Committee on the Environment, Public Health and Food Safety, the committee strongly advocates harmonisation of the regulation on food contact materials (FCM).

The draft motion, among other things, recommends:

  • better coordination between REACH and the FCM legislation, especially as regards substances classified as SVHCs (substances of very high concern) under REACH, and to ensure that harmful substances phased out under REACH are also phased out in FCMs;
  • development of a single EU standard for analytical testing in order to ensure that FCMs are tested by companies and competent authorities across the EU using one and the same method;
  • to take into account both substances used in the manufacture and processing and non-intentionally added substances (NIAS);
  • to take account of the so-called cocktail effect or multiple exposures for future risk assessment procedures - and to consider this when determining migration limits.

The draft motion also recommends that the Commission prioritise specific EU measures for paper, board, coatings, inks and adhesives. View the report here.

A plenary vote by the EU Parliament on the recommendations from the committee is expected in October 2016.

For more information on food contact materials and food regulation, please contact

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


Call for more date on sulfites to evaluate safety

EFSA has just released a scientific opinion on re-evaluation of sulfites, in part based on a pre-evaluation carried out by DHI in 2010. The current combined safety level for seven sulfites used as additives in wine, juices and other foods is sufficiently protective for consumers. However, EFSA will revisit this conclusion when data from new studies are provided to fill information gaps, reduce uncertainties and fully confirm their safety for consumers.

EFSA is urging producers and users of food additives to provide available information on the sulfites to complete the safety assessments.

The following seven sulfites is to be evaluated: sulfur dioxide (E 220), sodium sulfite (E 221), sodium bisulfite (E 222), sodium metabisulfite (E 223), potassium metabisulfite (E 224), calcium sulfite (E 226), calcium bisulfite (E 227) and potassium bisulfite (E 228).

For more information on sulfites and food additives, please contact

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


Amendment of Danish regulation on drinking water installations

A public hearing has been launched concerning the Danish regulation on approval of building components that come into contact with drinking water, also known as a GDV approval. According to the regulation, fittings, pipes, valves etc. must be evaluated for release or migration of chemical substances before they can obtain approval.

German or Swedish certification to be valid for Danish approval
In the public hearing from the Danish Transport and Construction Agency, it is proposed that products that have already obtained certification in either Germany or Sweden in future will automatically be approved for the Danish market. As a result, it will no longer be necessary to obtain the special Danish GDV approval. Remaining products, i.e. without a German or Swedish certification, will still be subject to obtain a GDV approval before the products are marketed in Denmark.

The drop mark will disappear
Furthermore, it is proposed that building components will no longer have to be marked with the drop approval mark. This scheme was launched in April 2014 and thus has only been valid for two years.

For more than 20 years, we have evaluated components that come into contact with drinking water and have considerable experience with what type of materials that may cause concern with regard to health. It is not evident from the public hearing, if the Transport and Construction Agency has considered possible impact on the drinking water quality. Naturally, we will follow future developments closely.

For more information on approval, please contact

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


Meet us

Food Legislation 2016 – Denmark
Senior Toxicologist Helle Buchardt Boyd is invited to give a presentation on novel foods at the Danish Food Legislation 2016 conference, which takes place on 14 – 15 June in Copenhagen.

SEPAWA Seminar - Germany
Senior consultant Michael Fink is invited to give a talk at a seminar of the German branch of SEPAWA, the European association of detergents, cosmetics and fragrances. Michael will talk about the progress in approval of biocidal active substances. The seminar takes place on 30 June in Frankfurt am Main.

Copenhagen Chemicals Summit 2016 - Denmark
Senior consultant Anne Rathmann Pedersen has been invited to speak about Chemicals and Sustainable Construction. The summit takes place on 28-29 September in Copenhagen.

ECSA 56 Coastal systems in transition - Germany
DHI will have a stand at the conference ECSA 56 Coastal systems in transition: From a natural to an anthropogenically-modified state, which takes place in Bremen on 4-7 September. Meet Lead biologist Louise Schlüter and Consultant Merete Allerup.


Courses

View all our courses here.


Contact

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Tel: +45 4516 9200 | Fax: +45 4516 9292 | www.tox.dhigroup.com



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