Newsletter on Chemicals and Regulatory Toxicology

May 2018


Medical devices

Two phenols banned in medical devices after January 2021 - apply for continued use now

In the EU, two groups of phenols still used in in-vitro diagnostics and other medical devices are to be phased-out by January 2021. Application for continued use should be initiated now and submitted from 7 - 21 May 2019.

The ban concerns nonylphenol ethoxylates (NPEs) and octylphenol ethoxylates (OPEs, including the Triton series). Both substance groups are included on ECHA’s Authorisation List and must be phased out by January 2021. The substances may be used after January 2021, but this requires that the manufacturer or supplier is granted a specific authorisation for the continued use.

A number of exemptions apply:


  • Use for scientific research and development (R&D) for less than one ton per year per company.
  • Use in analyses is regarded as R&D (including control and calibration). Such uses are exempted if the substance itself is part of the analysis, for instance if it is used in an analysis kit.

An exemption only applies, if the use takes place under controlled conditions.

The substance must be a part of the actual analysis. If the substance is used in the production of components for later use, such as a test kit, the use is not exempted.

Precautionary measures to protect the environment
Use under controlled conditions implies that special procedures, training etc. are implemented. It is also important to minimize waste and discharge of waste to the environment. That the substances are used only in the laboratory is not sufficient to claim use under controlled conditions. Special precautionary measures must be implemented to ensure that the substances are not released to the environment through waste water or waste.

43 substances require authorisation
The Authorisation List under the REACH Regulation now includes 43 substances that are considered as Substance of Very High Concern (SVHC) due to their health or environmental impact. The aim is to phase out these substances over time. The list is updated annually and it is essential for companies to know if they are using substances from the list in their current - or planned future - production or product portfolio. In that case an authorisation is required for continued use.

Authorisation for use of substances with environmental impact
The NPEs and OPEs are included on the Authorisation List due to their impact on the environment. For continued use after January 2021, you must have an authorisation.

Authorisation is, however, not required for substances in medical devices that are included in the Authorisation List only due to their health effects. Health and safety is assessed in connection with the European Medical Device Regulation (MDR). But if a substance is on the list because of its environmental hazards you must obtain an authorisation for continued use.

For more information about substances in medical devices, please contact:

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

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


Canada classifies disinfectants and sterilants as medical devices

With effect from 16 March, Health Canada has adopted new rules for use of biocidal disinfectants and sterilant solutions on medical devices and now classifies disinfectants and sterilants as medicial devices. Furthermore, medical device disinfectants and sterilants that do not comply with the definition of an antimicrobial agent in the Food and Drug Regulations (FDR) are also subject to the Medical Devices Regulation.

Manufacturers of disinfectants and sterilants that already have a market authorisation are granted an 18-month transition period to obtain the necessary licence. By 16 September 2019, the products must comply with the new rules.

All new applications for market authorisation of disinfectants and sterilants are subject to the new regulatory procedure with immediate effect. This includes devices imported or sold in Canada.

Safety and effectiveness compliance
Equivalent to the European medical device regulation, safety has high priority with the Canadian authorities. Manufacturers of existing as well as new disinfectants and sterilants will have to provide data to prove the safety and effectiveness of their products.

More details are available in Health Canada’s notice on classification and licensing of high-level disinfectants and sterilants as medical devices.

For more information on regulation of medical devices, please contact:

Torben W. Schou
tws@dhigroup.com
Tel +45 4516 9504


Chemicals

ECHA becomes responsible for occupational exposure limits (OELs)

The European Commission has decided to transfer the responsibility for formulating occupational exposure limits (OELs) to ECHA’s risk assessment committee (RAC).

For some time, the Commission has been aware of an overlap between occupational exposure limits (OELs) prepared by the Scientific Committee on Occupational Exposure Limits (SCOEL) and the derived no-effect levels (DNELs) for workers in the REACH regulation. The purpose of reassigning the responsibility to RAC is to prevent confusion about the different methodologies for deriving OELs and DNELs and to attain uniform guidelines.

The Commission has requested RAC to establish OELs for carcinogenic substances, and RAC has just published OELs for three well-known carcinogenic substances/group of substances:

  • Acrylonitrile: 1 mg/m3 (as 8-hour average); 4 mg/m3 (as 15 min. limit value)
  • Benzene: 0.16 mg/m3 (as 8-hour average)
  • Nickel and its compounds: 0.005 mg/m3 (respirable dust) and 0.03 mg/m3 (inhalable dust) (both as 8-hour average)

For all three substances, it is now assumed that there is a lower threshold for the carcinogenic effect. Thus, the indicated OEL values are considered to fully protect against any carcinogenic risk from the substances.

View the RAC opinions on the above here

Paradigm shift for assessment of benzene
The assessment of benzene is a radical change to the previous WHO assessment. WHO has assessed that there is no safe lower limit for the carcinogenic effect of benzene. WHO has indicated that an indoor exposure level of 0.00017 mg/m3 would correspond to an increase in the cancer risk of one-in-a-million. The same risk applies to an exposure level in drinking water of 0.001 mg benzene/L.

New OEL for benzene
When converting the OEL value of benzene of 0.16 mg/m3 to a continuous exposure level for the general population this would correspond to a safe DNEL level of 0.04 mg/m3. This value is more than 200 times higher than the value of 0.00017 mg/m3 previously considered as safe for exposure of the general population.

For more information on exposure limits, please contact:

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


Information requirements for online sale of chemicals

In 2017, fifteen EU member states checked a total of 1,314 internet advertisements for sale of chemicals revealing that 82% were non-compliant with the CLP Regulation, article 48.

Consumer information requirements
When selling hazardous chemicals online, the hazardous properties indicated on the label must be clearly communicated if the chemical can be purchased without first seeing the label. There are no formal requirements for this. For pure substances consumers must as a minimum have access to information on substance classification, that is hazard classes and hazard categories.

For chemical mixtures the consumer should have information about hazard statements and supplemental hazard statements. It is also recommended to include hazard pictograms and signal word. Web shops may provide this information online via a copy of the hazard labelling.

The information must be available in the national language(s) in the market(s) where the chemical is sold

The full report is available here.

For more information, please contact:

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


Presentations from seminar on substitution of chemicals

Our Danish readers may be interested in the experience gained by companies to substitute chemicals of concern. The expertise was shared at a recent seminar in Copenhagen by the following companies:

View all presentations from the seminar.

The seminar was co-arranged by Kemi i Kredsløb, a partnership aimed at reducing the use of harmful chemicals in products. DHI is one of the partners in Kemi i Kredsløb.

For more information about substitution of chemicals, please contact:

Margrethe Winther-Nielsen
mwn@dhigroup.com
Tel +45 4516 9320


Biocides

Possible exclusion of pyrethrins and pyrethroids as active substances in biocidal products

The insecticides pyrethrins and pyrethroids are not currently supported by an active substance dossier. This is the consequence of redefinition of the pyrethrins and pyrethroids as active substances in biocidal products. Consequently, the substances have been removed from the Article 95 list of active biocidal substances and product suppliers under the EU Biocidal Products Regulation (BPR).

The substances will only remain in the Review Programme if an interested party will take on the role of participant by 9 November 2018. Until an interested party has taken on the role of participant, or until 9 November 2018, biocidal products based on pyrethrins and pyrethroids in the relevant product type combinations can remain on the market and be used.

After 9 November 2018
If no substance supplier has taken on the role of participant by 9 November 2018, pyrethrins and pyrethroids must be taken off the review program. If the substances are taken off the review programme, biocidal products containing these active substances may legally remain on the market only until the relevant national authority makes a decision of non-approval of the product.

The EU Commission has agreed to clarify the situation of relabeling products containing these active substances following the redefinition.

For more information on active substances in biocidal products, please contact:

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


Food

More transparency of food risk assessment in the EU

The European Commission has issued a proposal on the transparency and sustainability of the EU risk assessment in the food chain. There is no doubt that the proposal will raise concern in industry about protection of confidential data and confidential business secrets.

Union Register of Studies
The proposal will impact on the entire agri-food chain, including agrochemicals, feed and food additives, food enzymes, food flavourings and food contact materials. The intent is to establish a Union Register of commissioned risk assessment studies which will be made publicly available.

Confidentiality
Companies may request that data and other business secrets are keep confidential. However, it appears from revision of articles 39 and 61 in the draft Regulation on the transparency and sustainability of the EU risk assessment in the food chain that the European Food Safety Authority (EFSA) may accept to provide confidential information “upon verifiable justification” for the purpose of protecting public health.

Time frame
The EU Commission’s objective is that the proposal is adopted by May 2019. In that case, the regulation will become effective 18 months after its entry into force.

For more information, please contact:

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


Two antioxidants to be removed from EU list of food additives

In April, the European Commission proposed to remove the antioxidants octyl gallate (E311) and dodecyl gallate (E 312) from the EU list of food additives.

The proposal to remove the substances has been put forward as the European Food Safety Authority (EFSA), in connection with a reevaluation of food additives, has concluded that sufficient documentation to assess the toxicology of the substances has not been submitted. A public hearing about the proposal to remove the substances from the EU list has also been conducted.

When the proposal is adopted by the EU Commission it will become effective 20 days from publication in the Official Journal of the European Union.

For more information about food additives, please contact:

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


Aluminium risks to be communicated more clearly

Consumer awareness of the possible migration of aluminium from food packaging or containers to food products is high. Public perception, however, often differs from the scientific assessment of health risks.

Consumers have sound reasons to be cautious about aluminium as some are likely to exceed the tolerable weekly intake limit value of 1 mg/body weight, set by the European Food Safety Authority (EFSA). Aluminium migrates particularly to acidic foods or foods containing salt.

Aluminium and barbecuing
It is a well-known assumption that using stainless steel trays for barbecuing or storing of food is preferable to using aluminium foil or trays. What is less well known is that food may be barbecued in aluminium foil or trays as long as the food is salted or spiced after grilling.

It is also a common belief that aluminium constitutes a cancer risk despite the fact that there is no scientific evidence for this. The health risk related to aluminium concerns effects on the nervous system, on fertility and unborn life. If aluminium is not excreted via the kidneys, it will accumulate in the body.

The findings concerning mistaken consumer perception appear from a special on aluminium in the food sector carried out by BfR, the German Federal Institute for Risk Assessment. This means that recommendations from risk assessments need to be communicated more clearly and systematically to avoid faulty handling of aluminium packaging and food containers. BfR’s advice is to reduce intake of aluminium when possible.

For more information on aluminium in food contact materials, please contact:

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


Nanoproject on food packaging to extend shelf life

NanoPack is an ongoing research project with the purposing of developing a new type of active food packaging to extend food shelf life. The packaging will consist of functional polymer nanocomposites from natural halloysite nanotubes with natural essential oils exhibiting antimicrobial properties.

As part of its activities, the NanoPack consortium has delivered a report on Ensuring compliance with ethics requirements and updated regulatory requirement on safety related to engineered nanoparticles and –materials. The report will be updated annually.

DHI participates as research partner and is responsible for the work packages on human and environmental safety. This implies safety assessment and recommendation of risk management measures during handling and disposal of the nanotubes, as well as keeping the NanoPack consortium updated with legislation on registration according to REACH and safety related to nanomaterials.

NanoPack is an EU research project under Horizon 2020 (Project ID: 720815). The project was initiated in January 2017 and will run until the end of 2019.

For more information, please contact:

Margrethe Winther-Nielsen
mwn@dhigroup.com
Tel +45 4516 9320


Webinar

Free webinar: A transparent supply chain in a circular economy – 23. May – Online


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