Newsletter on Chemicals and Regulatory Toxicology

March 2019


Chemicals

Pre-register chemicals under K-REACH before 30 June

Manufacturers and importers of chemicals subject to the Korean K-REACH regulation should be aware of the pre-registration deadline of 30 June 2019.

This concerns the manufacture or import of 1 ton or more of an existing chemical or 100 kg or more of a new chemical annually. Chemicals must be registered before the end of June to enjoy a 6-month grace period.

If pre-registration is not completed by 30 June 2019, manufacture, import, sales and use of existing chemicals of more than 1 ton annually will be unlawful after 6 months, and the manufacturer or importer may be subject to a penalty.

The above is the result of an amendment of the K-REACH regulation. It also includes existing substances that has already been imported and for which the annual import exceeds 1 ton or more. These substances must also be pre-registered before the deadline.

Through our long-standing collaboration with the Korea Institute of Science and Technology, KIST, we can assist you in fulfilling notifications to the Korean authorities.

For more details, please contact:

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


ECHA to recommend occupational exposure limits (OELs)

After ECHA’s Risk Assessment Committee (RAC) has taken over the work from the Scientific Committee of Occupational Exposure Limits (SCOEL), ECHA will from 2020 and onwards give recommendations for 4-5 occupational exposure limits (OELs) per year. This follows the agreement between ECHA and the European Commission to ensure coherence in the regulatory guidelines for protection of workers exposed to hazardous chemicals in the workplace

RAC will review and adopt scientific opinions on OELs, which will then be submitted to the Commission for further decision. Through public consultations ECHA will ensure a transparent process. The first substances to be evaluated with a view to provide recommendations for OELs are lead and its compounds and diisocyanates.

Requiring an OEL now?
If you are using substances not covered by an EU or national OEL value, you can contact us for assistance as we have comprehensive knowledge of and experience in deriving OEL-values.

For more information on OELs, please contact:

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


QSAR Toolbox updated with improved prediction models

Version 4.3 is the latest version of the OECD QSAR Toolbox and includes updated data from approximately 12000 REACH registrations. The Toolbox is developed for REACH purposes and can be used for hazard assessment of chemicals using grouping of chemicals and read-across.

Additional new features include:

  • New database on adsorption, distribution, metabolism and elimination (ADME) properties
  • Further prediction possibilities on acute oral toxicity, blood brain barrier transport, oral absorption and skin permeability
  • Further development of ChemID search possibilities

Besides using predictions from the Toolbox for REACH purposes, the Toolbox is also applicable for hazard assessment of chemicals used in cosmetic formulations, biocidal formulations and medical devices.

For more information on the OECD QSAR Toolbox, other in silico prediction tools and alternative test methods, please contact:

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

Daniel Vest Christophersen
dvch@dhigroup.com
Tel +45 4516 9469


Danish workplace instructions on hazardous chemicals to terminate

As of 1 July 2019, the Danish requirement for written workplace instructions for hazardous chemicals will no longer be mandatory.

In the future, the employer must make sure that staff working with hazardous chemicals receives oral instructions in the safe use of the chemicals. The instructions must include information on exposure limit values, curing time for epoxy and isocyanate products, use of personal protective equipment, disposal of waste etc.

These instructions must be based on the mandatory workplace risk assessment.

For more information, please contact:

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


CLP leaflet in 23 languages

ECHA has translated the leaflet on classifying and labelling chemicals in the EU and it is now available in 23 languages.

The leaflet contains a brief summary of the main action points you need to consider when classifying and labelling your products, in addition to advice and useful links. See all 23 leaflets here.

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

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


Biocides

June deadline for Korean BPR

If you are on the Korean market for biocidal products and as a result affected by the Korean biocidal product regulation, you should be aware of the upcoming deadline in June.

According to the Korean BPR, existing biocidal substances must be notified by 30 June 2019. Failure to notify will result in products being removed from the market by January 2020.

We have a long-standing collaboration with the Korea Institute of Science and Technology, KIST. Through KIST we can assist you in fulfilling notifications to the Korean biocidal authorities.

For more information, please contact:

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


Denmark controls biocidal products in food industry

As part of its regular inspection campaigns The Danish Veterinary and Food Administration (DVFA) will inspect food businesses in 2019 to check use of biocidal products, including correct labelling.

Food businesses should pay attention to the use of disinfectants, in particular that they use authorised disinfectants and follow instructions for use on the labels.

Suppliers of biocidal products should make sure that their products comply with the labelling schemes and other requirements according to EU harmonized or national rules.

The DVFA will have special focus on biocidal products during September – December 2019.

For more information on biocidal products, please contact:

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


Medical devices

New draft guideline on phthalates in medical devices

The EU’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) invites manufacturers and other stakeholders to comment on the Preliminary Guidelines for benefit-risk assessment of phthalates in medical devices. The deadline is 29 April 2019.

The Guideline describes the methodology on how to perform a benefit-risk assessment (BRA) of the presence of phthalates, which are carcinogenic, mutagenic or toxic to reproduction (CMR) and/or have endocrine-disrupting (ED) properties. This includes phthalates in both medical devices and/or parts or materials used therein at percentages above 0.1% by weight (w/w). The methodology of the guidance is suggested to be used for performing BRA of CMR/ED substances in general present in medical devices.

Comments must be submitted to SCHEER, and only comments submitted via SCHEER’s electronic template will be taken into account. For more details and link to the template, see the announcement on Public consultation on phthalates in medical devices.

For information on phthalates, CMR and ED substances and potential alternatives, please contact:

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


Food

EU consultation on FCM regulation

The European Commission is currently conducting a public consultation on evaluation of the EU regulation concerning food contact materials (FCM). You can have your say in the consultation until 6 May 2019.

The purpose of the evaluation is to assess whether the EU legislative framework for FCMs is fit for purpose and will cover the functioning of the FCM regulation in its entirety. It will also examine the situation concerning materials for which there are no EU measures and which are subject to permitted national measures.

More information and link to the public consultation here.

For more information about food contact materials, please contact:

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


Open consultation on phthalates in plastic FCMs

EFSA has launched an open consultation on the draft scientific opinion on the risk assessment of five phthalates for use in plastic food contact materials. The five phthalates are DBP, BBP, DEHP, DINP and DIDP.

It is worth mentioning that EFSA proposes a group tolerable daily intake (TDI) for DBP, BBP, DEHP and DINP because of their antiandrogen properties.

Written comments must be submitted by 14 April 2019 using the electronic template available on EFSA’s website.

For more information, please contact:

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


Ecolabelling of liquid food packaging

It is now possible to obtain the Nordic Swan Ecolabel for liquid food packaging.

This covers packaging of cardboard, plastic, aluminium and glass used for foods such as milk and juice. The final product will be a combination of an ecolabelled packaging with a non-ecolabelled content.

To obtain the Swan Ecolabel the packaging must fulfil certain requirements:

  • It must be made of at least 90% renewable materials or at least 80% recycled materials.
  • Requirements to the chemical content to increase reusability. This means a ban on the use of fluorine substances, phthalates, bisphenol A, S and F as well as PVC.
  • Raw materials of wood must be traceable and certified.
  • Design.
  • Labelling must include sorting sign and text.

We have extensive experience with eco-labels and help companies to apply for eco-labelling. If you are interested in pursuing the options for ecolabelling we can help you in fulfilling the criteria, including application to the authorities.

For more information, please contact:

Tina Slothuus
tsl@dhigroup.com
Tel +45 4516


Denmark aims for ban on fluorinated chemicals in FCMs

Denmark may become the first country in the world to ban the use of all organic fluorinated substances in food contact materials (FCM) of cardboard and paper. The Danish Veterinary and Food Administration is currently pursuing the options of a ban.

In late 2018, the European Food Safety Authority (EFSA) published a risk assessment of the fluorinated substances PFOS and PFOA, concluding that the substances constitute a much greater health concern than previously estimated. Denmark is concerned that other fluorinated substances may also be more harmful than expected. Instead of waiting for tighter EU regulation, the Danish authorities want to implement a national ban on all organic fluorinated substances in cardboard and paper FCMs.

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

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



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