Newsletter on Chemicals and Regulatory Toxicology

February 2018




Chemicals and biocides

News from ECHA Stakeholders’ Day

Some important messages from the ECHA Stakeholders’ meeting in Helsinki in January, the last meeting before the REACH registration deadline on 31 May 2018.

ECHA strongly encourages registrants to submit registration dossiers by the end of March at the latest to secure a registration number before the registration deadline. Dossiers submitted after end March will receive feedback from ECHA around August 2018, and it will not be possible to update dossiers before receiving feedback from ECHA.

Other valuable messages from the Stakeholders’ Day were:

Registration and dossiers

Around 70% of the registration dossiers received by ECHA are for substances imported into the EU. Although the final number of registrations remains to be seen, ECHA anticipates submission of roughly 40,000 more dossiers before the deadline. Companies that have not yet begun working on their registration dossiers should act now.

ECHA stressed that the phase-in period for substances covered by REACH is finalised with the May 2018 registration deadline. Consequently, any company, which would like to manufacture or import a chemical substance in quantities of 1 t/year or more after the May 2018 deadline, must have a valid REACH registration to be on the EU market. It was also noted by ECHA that pre-registration numbers are invalid after the May 2018 deadline, meaning that a new registrant needs to submit an inquiry dossier before submitting a registration dossier to ECHA.

Secure long-lasting data sharing agreements

The forums for data sharing, SIEFs, will no longer exist after the 2018 deadline. Consequently, ECHA suggests that data sharing agreements should be ready and valid for 12 years after registration.

Support for SMEs

SMEs that need financial support to comply with their REACH obligations may be qualified for such aid. Please check with your national helpdesks if you qualify for support.

For more information from the ECHA Stakeholders’ Day, please contact:

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


Help to REACH registrants in exceptional cases

ECHA offers help to companies that face exceptional situations and are not able to comply with their REACH registration obligations on time. These are situations where registrants through no fault of their own may not be able to submit a registration dossier by 31 May 2018.

The four scenarios comprising exceptional situations are:

  • Completeness of dossiers
  • Legal entity change
  • Dependency on the lead registrant
  • Substance with no registration intentions

More information is available on ECHA’s website.

Companies must provide detailed justification and explain what measures they have taken to comply with their obligations. ECHA must receive notice as soon as possible and by 24 May 2018 at the latest.

For further information on REACH registrations, please contact

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


Danish EPA updates advisory list for self-classification of chemicals

The advisory list for self-classification of chemicals issued by the Danish EPA has been updated and now includes predicted classifications for more than 50,000 substances.

The updated predictions have been assessed together with the Danish DTU National Food Institute using QSAR analyses, i.e. computer based predictions for chemical properties.

Under the European CLP regulation, companies must assess whether their chemical substances and mixtures are dangerous and subject to classification and labelling. This can be a difficult task if you lack data on the substances. The advisory list is a help to companies that must self-classify their chemicals.

The advisory list is in Danish, but you can search using CAS numbers or EINECS names and numbers.

For more information on classification and labelling of chemicals, please contact:

Henriette Christiansen
hc@dhigroup.com
Tel +45 4516 9422


New EU criteria for endocrine disruptors in biocidal products

New EU criteria for identifying endocrine disruptors in biocidal products entered into force on 7 December 2017. They will apply from 7 June 2018 to all new and ongoing applications for biocides.

The scientific criteria are based on the World Health Organization’s (WHO) definitions of endocrine disruptors and their adverse effects. The criteria were adopted by the EU Commission in the context of the Biocidal Products Regulation (BPR).

View the new criteria for determination of endocrine-disrupting properties.

Guidance document

A guidance document for applying the criteria for identification of endocrine disruptors is under development. The guidance is scheduled to be available by June 2018.

For more information on biocidal products, please contact:

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


Life Science

Pain reliever may harm unborn children

A new study again shows that women’s use of pain relievers containing endocrine disrupting substances in the first trimester of pregnancy may harm the cognitive development of children.

This time a Swedish study indicates that girls’ – but not boys’ - language development at the age of 30 months was impaired if the mother had used the pain reliever Paracetamol during the first trimester. Previous studies have also established endocrine disrupting effects in unborn children. Paracetamol is a common pain reliever and is also known as Tylenol and Panadol.

The Swedish study Prenatal exposure to acetaminophen and children's language development at 30 months is published in the scientific journal European Psychiatry.

For more information on endocrine disrupting substances in pharmaceuticals, please contact

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


Food and feed

Guidance on microbiological criteria

Microbiological criteria are used to ensure the safety of foods in primary production and food processing. The setting of such criteria should be transparent and based on scientific grounds.

EFSA has published a Guidance on the requirements for the development of microbiological criteria to help set criteria for both pathogenic bacteria and indicator bacteria. This guidance can be an inspiration for risk assessors and risk managers.

If you have questions about microbiological risk assessment in food processing, please contact:

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


New sources of protein for fish feed

The shortage of fishmeal increases the demand for alternative sources of protein for the expanding aquaculture industry.

As of 1 July 2017 insects may be used in fish feed in the EU after an adaption in the TSE*) regulation. Other possible sources of protein is the use of single cell protein or yeast from fermentation of cellulose, or single cell protein from fermentation of methane gas. For a review, please refer to the publications Fish Feed from wood and Yeast derived from lignocellulosic biomass


For questions concerning feed and feed additives, please contact:

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

*TSE, or Transmissible Spongiform Encephalopathy, is the generic term for prion diseases affecting the brain.


Recycling of plastic packaging for food contact

Across the world, plastic makes up 85% of the waste washed up on beaches. The majority is packaging, but only 5% of all plastic packaging stays in circulation, so the potential for recycling is huge.

Politically, the pressure to recycle plastic is increasing. In January, the European Commission adopted its first-ever Europe-wide Plastics Strategy to curb plastic waste and encourage recycling. This will be followed up by national action plans.


Recycling of food packaging lags behind


Reuse of plastics for food contact has been regulated since 2008. To reuse a material for food contact you must apply for approval of the recycling process. EFSA has assessed approx. 100 processes and many of these favourably, especially for PET, a very common constituent in plastic packaging. However, so far the Commission has not granted a single approval. The adaptation of the Plastics Strategy will undoubtedly increase the pressure for process approvals.

A critical obstacle for recycling for food contact materials is the content of problematic substances (SVHC substances). At DHI, we are engaged in development of tools designed to assist companies in the supply chain to avoid problematic substances. In addition, we are examining environmental labels to create a tool to identify eco-labels applicable for packaging. This will help users in the supply chain responsible for purchase of packaging and raw materials.

If you want to know more about our projects or about recycling of plastics, please contact:

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


Cosmetics

New limits for peanut oil and wheat in cosmetics

A new EU Commission Regulation limits the levels of peanut protein and hydrolysed wheat protein in cosmetic products.

The peanut protein level of peanut oil including its extracts and its derivatives is limited to maximum 0.5 ppm. In addition, the molecular weight average of peptides in hydrolysed wheat protein is limited to a maximum of 3.5 kDa. The new regulation 2017/2228 will apply from 25 September 2018 and will be fully implemented from 25 December 2018.

Concern for sensitisation and anaphylactic shock

The regulation is caused by several EU Member States indicating safety problems in relation to the use of peanut oil in cosmetic products. Concerns have been raised that sensitisation to peanuts might be induced through skin exposure to peanut oil by cosmetic products. For wheat protein, a number of cases of contact urticaria provoked by cosmetic products have been reported followed by anaphylactic shock after the ingestion of food containing wheat proteins.

Link to Commission Regulation (EU) 2017/2228 on cosmetic products.

For more information on cosmetics regulation, please contact:

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


Safety of ingredients for UV-curing of artificial nails

The European Scientific Committee on Consumer Safety (SCCS) has studied the use of the two urethane acrylates HEMA and Di-HEMA-TMHDC for curing of artificial nails.

It is SCCS’s opinion that in concentrations of up to 35 % (HEMA) and 99 % (Di-HEMA-TMHDC) respectively, the substances do not constitute a risk in connection with UV-curing of artificial nails. It is important that contact with the adjacent skin is avoided. Any acrylic gel on the skin must be wiped off immediately and the skin washed with soap and water.


May cause allergy

Urethane acrylates may cause allergy if in direct contact with the skin or respiratory problems if inhaled via vapours or dust from polishing. Any skin or respiratory problems with acrylic gels should be notified to the retailers. Professional users must use double nitrile gloves when applying acrylic gels.

For more in-depth details, please refer to SCCS’s Opinion on the safety of cosmetic ingredients HEMA and Di-HEMA 20 Trimethylhexyl Dicarbamate

For questions concerning the safety of cosmetics, please contact:

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


Meet us

ChemCon The Americas 2018 - USA
Helle Westphal and Henriette Christiansen will participate in ChemCon’s The Americas conference, which takes place in New Orleans, USA, on 5-9 February 2018.

Medico Bazar 2018– Copenhagen
We will host a stand at the Medico Bazar on 7 March which takes place at the Technical University of Denmark.

Society of Toxicology ToxExpo - USA
Brian S. Nielsen attends the Society of Toxicology's 57th Annual Meeting and ToxExpo on 11-15 March. The ToxExpo takes place in San Antonio, Texas.

Fresenius Detergents and Cleaning Products Conference - Germany
Michael Fink has been invited to speak about Regulatory Aspects: Update on Disinfectants under the BPR at the 10th International Fresenius Conference about Detergents and Cleaning Products. The conference is held on 26 - 27 April in Mainz, Germany.



Contact

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DHI | Agern Allé 5 | 2970 Hørsholm | Denmark
Tel: +45 4516 9200 | Fax: +45 4516 9292 | www.tox.dhigroup.com



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