Newsletter on Chemicals and Regulatory Toxicology

January 2019


Chemicals

China adds new substances to Inventory of Chemical Substances

In January 28 new substances have been added to the Inventory of Existing Chemical Substances in China (IECSC).

You can view the 28 substances here. Most information is in Chinese, however, substance names and CAS numbers are available in English.

Before you can import and use a substance, that is not listed in the IECSC, you must notify the substance with the Chinese Ministry of Environment. When the substance is assessed to fulfil the requirements, it is listed in the Inventory. This includes import of the substance both in its pure form and as part of a product.

For more information on substance notification, please contact:

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


Upcoming inspections to check REACH compliance

Throughout 2019, importers and manufacturer of substances in EU and EEA countries must be prepared for inspection of their REACH compliance.

The inspections are carried out to ensure that importers and manufacturers meet their obligations to register. This will include check of the registration dossier and duties such as updating the dossier.

Checks will be carried out for all tonnage bands with the main focus being on quantities of 1-100 tonnes per year. Checks will also include registered intermediates and whether they are used under strictly controlled conditions as well as substances registered as monomers in polymers.

The inspections are part of the EU enforcement project REF-7 and will be carried out by inspectors and custom authorities in all EU and EEA countries.

For more information, please contact:

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


Time to categorise your hazardous mixtures

ECHA recommends importers and downstream users of hazardous mixtures to get familiar with the European product categorisation system (EuPCS) as preparation for the new notification requirements under CLP, article 45.

EuPCS describes the intended use(s) of mixtures in a harmonised way. At the moment EuPCS contains about 250 different product categories that are expressed as a category name and a corresponding category code (e.g. name: Paints/coatings – Decorative, code: PC-PNT-2). When notifying a hazardous mixture to the EU poison centres, the responsible company must indicate – as part of the submission information – the product category best describing the main intended use of the mixture. Product categories that are excluded from the scope of the CLP Regulation are not listed in EuPCS. This includes cosmetic products and medical devices.

The EuPCS is a dynamic system and will be updated in order to be compliant with regulatory changes and requirements from industry and authorities.

More details about EuPCS and hazardous mixtures.

EU poison centres
The national poison centres provide medical advice on health emergencies arising from exposure to hazardous chemicals. Under the CLP Regulation, companies placing hazardous mixtures on the market have an obligation to provide information about these mixtures to their national poison centre.

For more information about classification of substances and hazardous mixtures, please contact:

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


Six new substances on REACH Candidate List

ECHA has added six new substances to the Candidate List of substances of very high concern (SVHCs). The substances are thus one step closer to be included on the Authorisation List and requiring permission for continued use.

  • 2,2-bis(4'-hydroxyphenyl)-4-methylpentane
  • Benzo[k]fluoranthene
  • Fluoranthene
  • Phenanthrene
  • Pyrene
  • 1,7,7-trimethyl-3-(phenylmethylene)bicyclo[2.2.1]heptan-2-one

For more information, please contact:

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


Life Science

Consultation on restricted use of DEHP and three other phthalates

Producers of medical devices and food contact materials should be aware of the public consultation launched by ECHA to amend the use of four phthalates. With the amendment the use of the phthalates will be further restricted, and some currently exempted uses may require authorisation.

Besides DEHP (bis(2-ethylhexyl) phthalate) the substances comprise:

  • BBP (benzyl butyl phthalate)
  • DBP (dibutyl phthalate)
  • test
  • DIBP (diisobutyl phthalate)

DEHP in medical devices requires REACH authorisation
All four substances are identified as SVHCs and included on the REACH Authorisation List due to their reprotoxic and endocrine disrupting properties. In addition, DEHP has effects on the environment. Consequently, DEHP requires approval for use in medical devices in order to comply with the REACH Regulation.

The deadline for comments to the public consultation is 12 March 2019. More information and links for submitting comments are available on ECHA’s website here.

For advice on phthalates and substitution, please contact:

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


Transport of dangerous goods

Corrosive chemicals in the new ADR

New amendments apply to corrosive chemicals in the 2019 edition of International Carriage of Dangerous Goods by Road (ADR). The amendments relate to section 2.2.8 concerning classification of corrosive substances. The principles now correspond to the GHS principles, which is important for allocation of packing groups (PG).

Packing groups for new substances and mixtures are allocated based on the impact time that may cause irreversible damage to undamaged skin tissue. Firstly, existing data on humans and animals must be analysed, including information from single exposures or from repeated exposures. In addition, evidence from incidents in which humans have been unintentionally exposed must be considered. If such data is not available, test data according to OECD Test Guideline 4045 or 4356 must be applied.

Classification of mixtures
Instead of tests, mixtures may be classified and assigned to packing groups by other methods such as bridging principles or methods of calculation based on the classification of the substances in the mixture.

ADR 2019 became effective on 1 January 2019 with a transitional period of 6 months. Compliance with the above is optional from 1 January and mandatory as of 1 July 2019.

Links to ADR 2019 is available on UNECE’s website.

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

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


Ecolabelling

Ecolabelling of products

The number of certification schemes designed to advance green development is growing. Currently, there are more than 465 ecolabels worldwide according to the global directory Ecolabel Index.

Requirements to ecolabelling go beyond the minimum regulatory requirements, and ecolabelled products must have as little impact on health and the environment as possible.

The Nordic Swan Ecolabel introduced criteria for labelling of cosmetic products in 2017. For the first time, products for intimate use have been granted the Swan Ecolabel based on these criteria. This means that they do not contain:

  • allergenic substances
  • parabens or other substances on the EU list of endocrine disrupting substances
  • microplast

Furthermore, the substances must be degradable in the environment, and the packaging must fulfil requirements to reduce materials and waste.

We are very experienced in helping companies to obtain ecolabel certification. We can help you in fulfilling the criteria for eco-labelling and with the application to the authorities.

For more information, please contact:

Tina Slothuus
tsl@dhigroup.com
Tel +45 4516 9547


Food

Consultation on ergot and ergot alkaloids

The European Commission has drafted a proposal for new maximum levels for ergot in cereals and ergot alkaloids, which will impact on flour, bread and cereals.

The Commission has issued a consultation on the draft levels and invites interested parties to submit responses, including supporting data, no later than on 8 February 2019.

View the draft possible maximum levels for ergot and ergot alkaloids here.

If you have questions concerning food and food safety, please contact:

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



Contact

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