Chemicals and Regulatory Toxicology Newsletter

September 2017




Chemicals

Global registration of chemicals

Regulatory demands increase worldwide. International suppliers of chemical substances should be prepared to address the challenge and may benefit from making core data sets and securing access to data.


REACH impact on regulation

The EU legislation on chemicals has set a new standard for registration of chemicals worldwide. Similar initiatives to strengthen the chemicals legislation are seen in many countries including China, Japan, Malaysia, Taiwan and Turkey. In the Republic of Korea, the new chemicals legislation (called K-REACH) became effective on 1 January 2015. Just like the EU legislation, K-REACH includes data requirements and risk assessment of all chemicals on the market.

This trend has a common background; a political intention to protect people and the environment from effects of hazardous chemicals. At the same time, there is a growing awareness of the lack of knowledge of the toxicological and ecotoxicological properties, and the actual use of large volumes of the substances on the market.


Address the challenge

International suppliers of chemical substances should be prepared to address this regulatory challenge by collecting available – or procure access to all necessary – substance data. In other words, you should create a core data set. Data should include substance identity, physical-chemical data as well as available toxicological and ecotoxicological data.


Restrictions on Letter of Access

Access to data obtained via a Letter of Access (LoA) from an EU based consortium is normally restricted for use only within the EU. A new agreement is required if registrations are made outside of the EU and often the LoA does not allow sublicensing to co-registrants. Together with the frequently high price for an LoA, these issues can be a barrier to the re-use of data across borders. Since GLP testing in qualified labs (OECD MAD compliant) is much cheaper in Asia, it is tempting to simply repeat the testing in order to get the full ownership.


Worries about double testing

The EU industry is concerned about duplication of tests. Not only does the duplication of test entail the use of additional test animals, but may also give different test results. These will have to be considered by the EU registrant in their dossier updating if the results become publicly available. Consequently, differing tests may mean more work.


Similar data requirements

The data requirements are similar in the EU, China and the Republic of Korea. In general, test following OECD standard methodologies from GLP certified (MAD compliant) laboratories can be used. Non-test methods such as read-across and QSAR backed by adequate justification are also accepted. Sharing of data on vertebrate test data is mandatory in Korea but not in China, although the Chinese authorities encourage this. The Korean legislation enforces data sharing but it is possible to waive this if a ‘justifiable reason’ can be given, such as for reasons of confidentiality. It is also possible for a Korean registrant to waive joint submission due to confidentiality or cost reasons.


Create a core data set

On a global scale, the requirements for registration of chemical substances are increasing. It is important for manufacturers and suppliers to prepare a strategy for their regulatory compliance in order to secure the markets. We advise clients to create a core data set for all substances in their portfolio and to clarify data ownership, access to data and their user rights. The mapping should be matched against the data required by the authorities in the relevant countries to identify data gaps to be filled.


For more information on global registration of chemicals, please contact:

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


GHS Revision 7

The 7th revision of GHS is now available online.
The most important changes are:

  • For mixtures containing substances classified in the hazard class Aspiration Hazard, the cut-off value for when a safety data sheet is required is reduced to 1% for the two categories in the class. The classification criteria remain the same.
  • Categories under Flammable gases are revised.
  • Improved specification of some classification criteria for flammable solids and desensitized explosives.
  • Examples on fold-out labels are added.
  • The following statements are amended: H230, H231, H232, P103 and P280.
  • A new P503 “Refer to manufacturer/supplier…for information on disposal/recovery/recycling” is added.
  • Allocation criteria for the following P-statements are amended: P103, P202, P231 + P232, P301, P301 + P312, P302, P302 + P352, P332, P375 and P501.

For more information on GHS, please contact:

Ilaria de Rosa Carstensen
idc@dhigroup.com
Tel +45 4516 9369


New guidance on CLP labelling of outer packaging

In July 2017, the Euro¬pean Chemicals Agency, ECHA, issued a Guidance on labelling and packaging. The guidance includes a new sub-section 5.4.2 that clarifies the issue of packaging used for consolidation of supply packaging during transport.


Transport packaging

The guidance introduces the term transport packaging. If the sole purpose of an outer packaging is to protect the chemicals during transport, this transport packaging is outside the scope of the CLP Regulation and does not require a CLP label. This also applies if the packaging is not labelled according to the labelling provisions of transport of dangerous goods.

Furthermore, suppliers and distributors may store substances and mixtures on site without being removed from the transport packing if the goods are awaiting further transport. When the substance and mixtures are no longer in transport they must be removed from the transport packaging and a CLP label must be clearly visible.


Consolidated supply packaging during transport

The aim of the new guidance is to prevent disagreements between the CLP labelling provisions and the transport of dangerous goods. The guidance will facilitate packaging of multiple chemicals with various CLP pictograms in the same transport packaging.

If the packaging of a substance or mixture consists of multiple layers and the outer packaging is not for transport only, all layers (inner, intermediate, outer) must still be labelled in accordance with the CLP Regulation.

For more information on CLP labelling, please contact:

Helle M. Andersen
hma@dhigroup.com
Tel +45 4516 9023

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

Ingelise Dige Semark
ids@dhigroup.com
Tel +45 4516 9221


Danish code number for titanium dioxide changed

The Danish Working Environment Authority has changed the number after the hyphen for the code number for titanium dioxide.

The change comprises titanium dioxide present in non-dust/non-powder products. From now on, the number after the hyphen must be -1 regardless of the concentration of titanium dioxide in the product.


Will impact on paint

It is a significant change compared to previous practice when the number after the hyphen was -3 in concentrations between 60% and 80% and -6 for concentrations of titanium dioxide above 80%. It will impact particularly on paint as titanium dioxide is often used in paint.

If other substances in a product contribute to a higher number after the hyphen, this is the deciding contribution.

For more information on Danish MAL-codes, please contact:

Helle M. Andersen hma@dhigroup.com
Tel +45 4516 9023


Improved ECHA guidance on substances in articles

The EU requirement to inform about SVHC substances above 0.1% in articles includes each component in an article. Several member state countries already interpret the regulation in this way. With the new guidance, ECHA wants to ensure a uniform interpretation of the regulation in all EU countries.

ECHA’s updated version 4 of the Guidance on requirements for substances in articles clarifies the obligations under REACH for companies that import and produce articles. These companies must communicate information on substances of very high concern (SVHCs) in articles.


Articles made of several article components

Version 4 also clarifies the requirements for articles consisting of several components, which are themselves articles. Articles consisting of several components are termed complex objects. The guidance specifies that:

  1. When notifying ECHA of SVHCs in articles, the percentage of SVHC substances must be calculated on:
    • the weight of the entire article, if the component articles “were made or assembled by other producers”,
    • or, in all other cases, the weight of the component article, in which the substance is present
  2. When communicating down the supply chain, the percentage of SVHC substances must be calculated on the weight of the component article, in which the substance is present.

The guidance includes a new subchapter on complex objects enriched with examples.

Version 4 is fully revised and aligned with the judgement of the European Court of Justice (case C-106/14).

For more information on substances in articles, please contact:

Ilaria de Rosa Carstensen
idc@dhigroup.com
Tel +45 4516 9369


Food and drinking water

Aluminium migration from food trays to food

Foods from uncoated aluminium trays can contain high levels of aluminium. This has been proven in a study by the German Federal Institute for Risk Assessment, BfR.


Hazard effects of aluminium

Aluminium is a natural component in drinking water and foods such as fruits and vegetables. In healthy humans, aluminium is excreted via the kidneys, but non-excreted aluminium can accumulate in the body and potentially harm the nervous system, fertility and the development of the embryo. Consequently, avoidable intake of aluminium should be reduced.


Limit values exceeded

All examined samples in BfR’s research study released aluminium in amounts that exceeded the European Council’s limit value by far. The limit value is 5 mg aluminium per kg food. Although the study included only a small number of samples, BfR concludes that the results are material-specific and can therefore be generalised.

Aluminium trays are commonly used for foods in day care centres, schools, canteens and catering services. The aluminium ions transfer to acidic foods such as juice, apple sauce and tomatoes, particularly during the reheating process. BfR’s advice is to reduce consumption of food that is kept warm in aluminium trays. This includes children and elderly people who eat food from aluminium trays daily or often.

More details are available in the BfR Opinion on Uncoated aluminium menu trays: First research results show high release of aluminium ions.

For more information on substances in food contact materials, please contact:

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


Potential new EU system for regulation of printed FCMs

The European Commission contemplates the possibility of appointing designated bodies to be responsible for compliance with new EU measures on printed food contact materials (FCMs).

The traditional approach to regulate FCMs includes the preparation of a positive list of authorised substances, determination of migration limits etc. However, this could be a very lengthy process considering the number of substances used in printed FCMs.


Transfer of responsibility

Another option is to assign the responsibility to designated bodies such as laboratories or consultants that must be independent from the FCM manufacturers. Based on standards and guidance issued by the Commission, the designated bodies should perform toxicological tests, carry out risk assessments and propose regulation on printed FCMs. All information concerning FCMs would be available to the authorities but with restricted access for FCM manufacturers.

The ongoing work for the new measures is expected to be finalised by mid-2018.

For more information on FCM regulation, please contact:

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


EU measures to reduce acrylamide in food

In spring 2018 a new EU regulation is expected to come into force which aims to reduce acrylamide in food. The proposed regulation will establish mitigation measures and benchmark levels in order to decrease the presence of acrylamide during the manufacturing process.


Mitigation measures and benchmark levels

Mitigation measures will be applied to identify food processing steps susceptible to the formation of acrylamide in foodstuffs. The benchmark levels will indicate levels for acrylamide content in food. The benchmarks will be reviewed regularly by the European Commission with the aim to set lower levels, reflecting the continuous reduction of the presence of acrylamide in food.

View the draft proposal for Commission Regulation on the application of control & mitigation measures to reduce the presence of acrylamide in food

Acrylamide is a carcinogenic substance formed during high temperature processing, particularly in potato-based products, cereals and coffee.

For further details on substances in food, please contact:

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


Denmark tightens up rules on drinking water pipes

There is an increased awareness of the drinking water quality in Europe. The Danish certification system DK-VAND wants to contribute to this by enhancing the requirements to drinking water equipment.

In Denmark, drinking water pipes of plastic carrying water from local waterworks to private households must fulfil the requirements of the DK-VAND certification. The purpose is to secure drinking water of the highest possible quality. DK-VAND wants to extend the certification also to include fittings, valves, pumps etc.


Other approval scheme for taps and fixtures

When the drinking water reaches a private household, another certification scheme applies. Components in contact with the drinking water in Danish households must carry a GDV approval. The GDV scheme was amended in 2016. Consequently, building components can be approved for use in Denmark if they have been approved by other certifying bodies, even though these schemes have no requirements for testing building components for migration of harmful substances.

It is the ambition of DK-VAND that the requirements for drinking water pipes will lead to similar requirements for building components used in drinking water installations.


About DK-VAND

DK-VAND consists of the Danish Plastics Federation, the industry association DANVA, waterworks and the trade association of Danish waterworks. Furthermore, DHI assesses migration of possible harmful substances, and the Danish Technological Institute carries out required tests and ensures that documentation is in compliance with the requirements.

For more information on drinking water quality, please contact:

Helle Westphal
hw@dhigroup.com
Tel +45 4516 9012


Medical Devices

Substitution of problematic substances in medical devices

When the new Medical Device Regulation (MDR) becomes effective, new obligations will be introduced for the content of problematic substances.

The requirements specifically address substances classified for carcinogenicity, mutagenicity or reproductive toxicity (CMR substances) in category 1A/1B, including phthalates, and substances defined as endocrine disruptors (EDCs). The MDR stipulates that justification for the use of these substances should be given for levels above 0.1%.


Substitution task not to be underestimated

Substitution of problematic substances puts pressure on producers of medical devices. In August, we hosted a workshop for the medical device industry on problematic chemical substances. Concern was expressed on how to handle the new requirements in order to be compliant with the new MDR and the In Vitro Diagnostic Regulation (IVDR).

Particularly, the required analysis of alternatives was in focus. Expertise in how to evaluate alternative substances is important. In addition, knowledge of the different elements of the substitution process is the key.

At the workshop, a successful case story on substituting the plasticiser DEHP with an alternative was presented by a major Danish medical device producer. The take-home message was that substitution is possible but it is a large task, which should not be underestimated.

DHI participates in a partnership on circular chemistry (KiK) that helps Danish enterprises reduce the use of chemicals of concern in their products. KiK has developed various tools, such as a database for substances of very high concern (SVHCs) based on material type and a database for alternative substances or production processes to substitute SVHCs.

For more information on substitution and regulatory compliance, please contact:

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


Cosmetics

Surveillance of children’s cosmetics

Too many children’s cosmetic products are either insufficiently labelled or contain banned or unauthorised use of substances concludes a Swedish survey. The survey was carried out by the Swedish Medical Products Agency in cooperation with Swedish municipal authorities.

Slightly less than one half of the controls (49%) showed one or more non-compliances. The survey covered mainly make-up products and tattoos applied on the skin with water. Besides non-compliance with labelling requirements, some products contained banned chemicals such as the allergenic preservative methylisothiazolinone/methylisothiazoline or the preservative isobutylparaben. Products containing these substances were removed from the Swedish market.

A brief summary in English is available in the Swedish report Barnkoll 2016 - Ett samverkansprojekt med kommunerna

For more information on cosmetic products, please contact:

Ann Detmer
ad@dhigroup.com
Tel +45 4516 9103


CMR classification prompts ban on use in cosmetics

If you use a cosmetic substance and the classification of the substance is updated to CMR, this will automatically cause a ban on use of the substance in cosmetic products.

CMR means that the substance is carcinogenic, mutagenic or toxic to reproduction. If a substance classification is amended to CMR, the automatic ban on use in cosmetics will automatically become effective. This is evident from paragraph 15 in the European regulation on cosmetic products, which has been effective since 1 December 2010. On certain conditions, the EU authorities may grant an exception for a restricted use of the substance.

It is the responsibility of manufacturers, importers and distributors that cosmetic products do not contain CMR substances.

For more information on the European cosmetics regulation, please contact:

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


Meet us at

Medical Devices Conference 2017, Sweden
Chief Toxicologist Poul Bo Larsen participates in the 2nd Symbioteq Biocompatibility Medical Devices Conference 2017 in Gothenburg, Sweden on 3-4 October.

Nordic Chemicals Summit 2017, Denmark
Senior Chemicals Consultant Jens Tørsløv will chair one of the sessions at the Nordic Chemicals Summit taking place in Copenhagen, Denmark on 10-11 October. You can also meet us at our stand.

Regulatory Summit Asia 2017, Singapore
Jens Tørsløv together with Business Development Manager Brian S. Nielsen will also participate in the Regulatory Summit Asia 2017 commencing on 20 November. The summit runs for four days and comprise biocides, chemicals regulation and food contact materials. We will be hosting a stand together with our partners from Korea Institute of Science and Technology (KIST).

Eurotox 2017, Slovak Republic
Chief Toxicologist Poul Bo Larsen and senior toxicologist Helle Buchardt Boyd participated in Eurotox 2017, the 53rd Congress of the European Societies of Toxicology in Bratislava, Slovak Republic, on 10-13 September. DHI presented a poster on Cumulative Risk Assessment of Chemical Exposure of Children and Unborn Children to Endocrine Disruptors and Neurotoxic Substances.


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