Newsletter on Chemicals and Regulatory Toxicology

March 2018




Chemicals

Extended waste producer responsibility

A revision of the six EU directives affecting waste in all of EU is expected to be adopted within the next couple of months. This will entail more ambitious goals for recycling and increase focus on measures to reduce waste.

For packaging producers and users respectively, it is not yet clear who will have the final responsibility for waste. The authorities will encourage incentives to increase recycling and lessen dumping of waste.

Producers of packaging accountable for waste

Waste producers, including producers of packaging waste, will get a financial and organisational responsibility for waste management. This means that the accountability of producers of packaging waste will increase.

Many producers and users of packaging are already involved in initiatives to increase recycling. At DHI we are involved in developing tools to avoid unwanted substances in recycling of packaging. If all operators in the value chain participate in the process the better the chance to obtain sustainable results.

For more information, please contact:

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


EU member states to check classification and labelling of mixtures

Throughout 2018 spot checks will carried out in the EU of the classification and labelling of mixtures.

Inspection may include other modules

In January 2018 a joint EU campaign was launched to check the classification and labelling of mixtures including consistency with the information presented in the safety data sheets. The inspections may include additional modules, for instance if the classification and labelling has been notified to ECHA or the authorisation and labelling of biocidal products.

The campaign is part of the ECHA enforcement project REACH-EN-FORCE-6 (REF-6). National authorities are responsible for inspections and a total of 31 European countries will participate.

Read more here.

Since 31 May 2017 it has been mandatory to classify and label chemical substances and mixtures in accordance with the CLP Regulation.

For more information on classification and labelling, please contact:

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


MIT gets harmonised classification and specific concentration limit

The EU member states have decided to adopt a harmonised classification and a specific concentration limit for classification as a skin sensitiser of the very allergenic substance Methylisothiazolinone, also known as MIT.

MIT is used as a preservative in cosmetic products, paints and detergents. Until now supplier classifications have been applicable as there has been no harmonised classification of the substance. Furthermore, a general classification limit for classification as a skin sensitiser of 1% has been applied.

The harmonised classification of MIT means that the substance must be classified as follows:

  • Acute Tox. 2; H330
  • Acute Tox. 3; 311
  • Acute Tox. 3; 301
  • Skin Corr. 1B; h314
  • Eye Dam. 1; H318
  • Skin Sens. 1A; H317
  • Aquatic Acute 1; H400
  • Aquatic Chronic 1; H410

In addition, a specific concentration limit for classification as Skin Sens. 1A of 0.0015% has been specified. It is expected that the harmonised classification and the classification limit for MIT will become effective from the end of 2019.

MIT in cosmetic products

The use of MIT in cosmetic leave-on products such as creams is banned. As of 28 April 2018 the limit for use of MIT in rinse-off products will be 0.0015%. Rinse-off products include shampoo, soap and shower gels.

For more information on substance classification, please contact:

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


Update on GHS implementation in Costa Rica

Last year the Costa Rican Ministry of Health published two executive decrees related to the implementation of GHS in Costa Rica: decree 40457-S Reglamento técnico RTCR 481:2015 Productos Químicos. Productos Químicos Peligrosos. Etiquetado and decree 40705-S Reglamento Técnico RTCR 478:2015 Productos Químicos. Productos Químicos Peligrosos, Registro, Importación y Control.

Decree 40457-S aligns the requirements for labelling of hazardous chemical products with UN GHS rev. 6. There is a transition period of 5 years (until 30 December 2022) for products already registered and placed on the market before 30 December 2017. Decree 40705-S describes requirements on registration of hazardous products.

Follow the global GHS implementation on our free GHS web portal or contact:

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


Control of chemicals lacking in imported goods

In 2017 the Swedish Chemicals Agency, KEMI, re-inspected companies previously reported for not fulfilling their obligations to inform about chemicals in their products. Most companies were reported again.

The most common offence was content of lead in electronic equipment. Other problematic substances such as short chain chlorinated paraffin and phthalates in soft plastics were found in toys and sports equipment.

The inspection proves that it is important that importers require precise information on specific substances in products from their suppliers. The majority of the products containing problematic substances are discount goods imported from countries outside of the EU. Consequently, it is likely that the problem exists in many other countries than Sweden. In Denmark, the EPA informs about similar findings such as lead in the popular toy fidget spinners.

For more information on problematic substances in products, please contact:

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


Biocides

Danish EPA suspends new applications for biocidal product authorisations

The increasing number of applications for biocidal product authorisations challenges European biocidal authorities and several EU member states report of capacity problems. Recently, the Danish EPA has announced that they are currently suspending new applications where Denmark is first country/reference member state. This applies to applications submitted in 2018 and 2019.

It is, however, still possible for industry to apply for product authorisation in Denmark through mutual recognition and to initiate a dialogue with the EPA about applications submitted in 2020 and onwards.

For more information, please contact:

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


Biocidal products authorisation of active chlorine based products or in situ generated peracetic acid

We are looking for companies applying for authorisation of active chlorine based products or in situ generated peracetic acid (peracetic acid generated from tetra-acetylethylenediamine (TAED) and sodium percarbonate), either as individual applicants or in a consortium. The deadline for application is 1 January 2019. This means that the dossier work for an application must be initiated now.

Benefit of consortia

The benefit of consortia for biocidal product families includes shared costs, while at the same time enabling you to maintain individual product authorisations independently.

Consortia are targeted producers, distributors and formulators placing biocidal products on the market and are of particular interest to small and medium sized enterprises (SMEs) within biocidal products and biocidal product families.

We have assisted many industry clients in setting up consortia and in obtaining authorisation of biocidal products and biocidal product families. In the consortia we act as facilitators for handling of confidential information and take care of consortia management, communication with regulatory bodies etc.

For more information on biocide consortia read here.

If you want to know more, you are welcome to contact:

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


Medical devices

Unravelling the regulatory ambiguities of MDR and REACH

Developing effective and safe medical devices is a lengthy process. In addition, it can be a daunting task to find ones way in the complex legislation. The new EU Medical Device Directive (MDR) and the In Vitro Device Directive (IVDR) increase the requirements for documentation of medical devices, while the EU chemicals regulation REACH may impact on the substances to be used in the devices.

The interface between the different types of legislation is often difficult to detect and sometimes the legislation in one sector may affect the legislation in another sector.

REACH authorisation for human health and environmental impact

A medical device manufactured in the EU may contain a problematic substance subject to authorisation under REACH. The substance is subject to authorisation if the problematic effects impact on human health. However, substances subject to authorisation for environmental reasons require a specific use permission under REACH.

There is a lot of focus on the new regulations and standards and you need to be on top of this to get a CE marking of your device. The many overlaps and ambiguities in the regulations may call for assistance with chemical registrations and application to authorities for authorisation of restricted substances.

We help companies to evaluate their product and to unravel the legal and regulatory issues. Furthermore, we can support you with assessment of the toxicity of materials and chemical substances, including biocompatibility evaluations and documentation, analyses of possible migration of chemical substances when using a medical device, and validation of risk assessments.

For more information, please consult:

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


Food contact materials

Bisphenol A: more stringent measures for FCMs

As of 6 September 2018, new regulation from the EU Commission will significantly tighten the use of bisphenol A (BPA) in food contact materials (FCMs).

The new regulation lowers the specific migration limit to 0.05 mg of BPA per kg of food (mg/kg) for plastic materials and articles, which is the amount allowed to migrate from the plastic material into food while keeping it safe. Furthermore, it extends this restriction to coating materials used to line food and drink cans.

The regulation also extends the ban from 2011 on the use of BPA in baby bottles by prohibiting the use of BPA to manufacture infant sippy cups. The ban also prohibits the migration of BPA from coated materials containing food intended for infants and children 0–3 year olds.

Declaration of compliance required

Food contact materials with laquered or coated surfaces must be accompanied by a declaration of compliance. Specifications needed are given in annex I to the Commission Regulation (EU) 2018/213 on the use of bisphenol A in varnishes and coatings intended to come into contact with food

For more information on migration from food contact materials, please contact:

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




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