Newsletter on Chemicals and Regulatory Toxicology

June 2019


Chemicals

12th adaption to CLP regulation published

In April the 12th adaptation to technical progress (ATP) to the CLP Regulation came into force. The adaption implements the sixth and seventh revised editions to the Globally Harmonised System (GHS) of Classification and Labelling in the EU.

The adaptation includes changes in annexes to the CLP Regulation such as:

  • Addition of a new hazard class for desensitised explosives (explosive chemicals in which the explosive properties are suppressed by adding for instance water).
  • Addition of a new hazard category for pyrophoric gasses (flammable gasses that are liable to ignite after brief contact with oxygen) in the hazard class for flammable gasses.
  • Clarification and consistency in corrections to ensure consistency with GHS terminology.
  • Definition of hazard classes has been updated to ensure a consistent terminology.
  • References to test methods such as ISO methods or OECD guidelines have been updated to reflect development in test methods.

The rules are effective from 17 October 2020 but may be used for classification and labelling already now.

View 12th adaption of the CLP Regulation in official EU languages

For more information, please contact:

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


New Zealand changes for hazardous substances and waste

New rules have been enforced in New Zealand as of 1 June for hazard substances in class 6 (toxic) and class 8 (corrosive) and for handling of hazardous waste.

Class 6 and 8 substances
For these substances you have to establish a hazardous substance location (HSL), which must meet specific requirements for capacity and storage. The HSL must be notified to WorkSafe, the New Zealand authority on hazardous substances. From 1 December 2019 a location compliance certificate will also be mandatory.

Read more on WorkSafes hjemmeside, including a quick guide to class 6 and 8 substances.

Hazardous waste
As of 1 June, hazardous waste is subject to most of the rules for the safe use, handling and storage of hazardous substances. This means that you need to include any hazardous waste used or stored at your site in your inventory and label any containers that hold hazardous waste.
Read more here.

For more information, please contact:

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


GHS – new revision end of 2019

The eighth revision of the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) is expected to be published by the end of 2019.

Below we list some of the main changes.

Hazard classes and hazard statements:

  • New hazard class under physical hazards: Chemicals under pressure. They are defined as “liquids or solids (e.g., pastes or powders), pressurized with a gas at a pressure of 200 kPa (gauge) or more at 20 °C in pressure receptacles other than aerosol dispensers and which are not classified as gases under pressure”
  • New hazard statements for the hazard class chemicals under pressure: H282, H283, H284
  • Classification criteria for Skin corrosion/irritation are better clarified

Precautionary statements and pictograms:

  • New and revised criteria for precautionary statements concerning medical response
  • Updated criteria for allocation of precautionary statements
  • Deletion of some P statements
  • New precautionary statements
  • Introduction of precautionary pictograms “Keep out of reach of children” as examples of pictograms that may be used to communicate precautionary information in more than one way

Other changes:

  • New labelling example for sets and kits
  • New “Guidance on other hazards not resulting in classification” – to facilitate the identification of other hazards that may need assessment and communication, which at the moment concerns dust explosions only.

For more information, please contact:

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


Free web tools

CheMigrator® - for calculation of migration from packaging materials

CheMigrator® is a new tool to help you calculate substance migration when designing packaging materials such as food contact materials (FCM) or materials for medical devices. It is also a valid tool for documenting the compliance of your material with the rules and standards for FCM and medical devices.

CheMigrator® comprises two databases:

  • A substance database with substance properties, such as hazard profiles and Specific Migration Limit values (SML), where available.)
  • A material database with properties relevant for evaluation of migration of each material together with a list of substances expected to be present in the material. Each substance is accompanied by an explanation of its possible presence in the material.

Once you have selected the material and substance of interest, it is possible to calculate the related diffusion and partition coefficients or to insert experimental data. You can then calculate the degree of migration from the selected substance and material of interest.

The output is a short report with a summary of the used input information together with the calculated concentration in the substrate, a comparison of the substance SML, if available, and the degree of leaching. The information can be saved.

Download CheMigrator®

Dorte Rasmussen
dor@dhigroup.com
Tel +45 4516 9316


eREACHNano: web tool with information for registration of nanomaterials

eREACHNano is a free web tool developed to help small and medium-sized companies who may not have sufficient in-house expertise in regulation on nanomaterials.

The tool is available in English and has been developed by a working group of the Nordic Council of Ministers, N-Nano, and DHI.

Through a series of small video animations, the data requirements for nanoforms according to the REACH guideline documents are explained, including:

  • Definition of nanomaterials
  • Types of nanomaterials
  • Overview of nanomaterial-specific annexes to existing REACH guidance
  • Chemical and physical characterisation of nanomaterials
  • Testing of nanomaterials
  • Exposure and risk assessment of nanomaterials

A specific revision of the REACH information requirements for nanomaterials was adopted by the European Commission in December 2018.The amendments clarify the information that companies placing substances in nanoform on the market need to provide in their registration dossiers. The new rules apply as of 1 January 2020.

eREACHNano does not include the new requirements of December 2018. These will be included in a subsequent version of the web-tool to be launched later this year.

The eREACHNano project is funded by the Nordic Council of Ministers, the Nordic Working Group for Chemicals, Environment, and Health, and by DHI.

You can access the web-tool on http://ereachnano.dhigroup.com

For more information, please contact:

Dorte Rasmussen
dor@dhigroup.com
Tel +45 4516 9316


Medical devices

Consultation on draft guideline for medical devices in combination products

The European Medicines Agency (EMA) has released a draft guideline on the quality requirements for medical devices in drug-device combinations for public consultation.

Drug-device combinations are medical devices in human medicines that include a device for the administration, dosing or use of the medicine.

The guideline addresses the new obligations in the EU Medical Devices Regulation (MDR 2017/745), in particular the requirements under Article 117. Article 117 foresees that a marketing authorisation application will include a CE certificate or declaration of conformity for the device or, in certain cases, an opinion from a notified body. In the draft guideline it is specified which information about the device that needs to be submitted as part of an initial marketing authorisation application.

Comments on the public consultation must be submitted by 31 August 2019.

Draft guideline: Quality requirements for drug-device combinations.

For more information, please contact:

Lise Lyck
lly@dhigroup.com
Tel +45 4516 9307


Portal on EU medical devices regulations revamped

To help smooth the transition to the new medical devices regulations, the European Commission has launched a revamped Medical Devices section on its website.

The updated website explains the main differences between the current directives and the new regulations on Medical Devices (MDR) and In Vitro Diagnostic Medical Devices (IVDR).

The new regulatory requirements are presented in various sections targeted at manufacturers, importers, health institutions, authorities in non-EU countries and others.

Comments on the public consultation must be submitted by 31 August 2019.

Infographic with deadlines for implementation of MDR and IVDR .

For further information, please contact:

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


Food

PET recycle process for FCM approved

The European Food Safety Authority, EFSA, has approved a recycling process of post‐consumer poly(ethylene terephthalate) (PET) flakes for use in food contact materials (FCM).

The PET flakes originate from materials and articles manufactured in accordance with the EU legislation on FCM and contains no more than 5% of PET from non‐food consumer applications. The PET flakes have been evaluated and approved not to be a risk to human health when used for contact with foodstuffs for long-term storage at room temperature, with or without hotfill. Articles made of this recycled PET are not intended to be used in microwave and conventional ovens.

The approved recycling process is based on the EREMA Multi-Purpose Reactor (MPR) technology and was submitted by the Italian company Alimpet S.r.L.

In the EU, recycling processes must be evaluated and authorised before the recycled plastic materials or articles are placed on the market for food contact.

For more information on food contact materials, please contact:

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


Avoid heating of sucralose

Heating of the sweetener sucralose may lead to the formation of chlorinated organic compounds with a health-damaging potential such as polychlorinated dibenzo-p-dioxins (PCDD), dibenzofurans (PCDF) and chloropropanols. This occurs especially when sucralose-containing foods such as canned vegetables or baked goods are heated.

It is the German Federal Institute for Risk Assessment, BfR, which has evaluated available data on sucralose. Until further assessments are available, the BfR recommends not to heat foods containing sucralose (E 955). This applies to consumers as well as to food manufacturers.

BfR opinion: Harmful compounds might be formed when foods containing the sweetener Sucralose are heated.

For more information on food, please contact:

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



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