News about Environment
and Toxicology

December 2014




Chemicals and biocides

Record dossiers expected for REACH 2018 deadline

The REACH Regulation leads to tremendous impact on the European industry, which manufactures or imports substances above 1 ton/year.

Form consortia for specific substances
At the REACH Congress in Düsseldorf in November 2014, conference speakers emphasised the importance of acting now towards the 2018 REACH deadline, which covers registrations of substances above 1 t/y. The Euro­pean Chemicals Agency (ECHA) expects to receive the highest number of dossier submissions yet (estimated to be above 70,000 dossiers). It is important that companies that register specific substances get together and form consortia to share the burden and make common registrations.

More dossiers from SMEs
Furthermore, service providers and testing laboratories are expected to be booked quickly. It was also emphasised that more small and medium-sized companies (SMEs) are expected to prepare REACH dossiers.  Consequently, more single submissions are expected for the 2018 deadline. This may well mean that non-testing alternatives such as read-across and QSARs will be used more for future dossiers. High expertise levels are essential to prepare dossiers at the quality required by ECHA.

From DHI, Poul Bo Larsen and Hülya Genc-Fuhrman attended the congress. It was well attended by all REACH stake holders and regulatory authorities. DHI participated as a service provider within all aspects of REACH.

For more information on REACH and the 2018 deadline, please contact

Hülya Genc-Fuhrman
hgf@dhigroup.com
Tel +45 4516 9256


Extended GHS deadlines in Singapore

Singapore’s GHS Taskforce has given chemical users an additional year to comply with GHS for mixtures. The deadline for workplace labelling of mixtures has been extended to 1 July 2016.

With the launch of Singapore Standard SS 586:2014 in March 2014, the implementation deadline for the newly adopted categories such as ozone depleting substances, chemically unstable gases, aerosols and sensitisers (based on GHS purple book Rev 4) is 1 July 2015.

You can find more information on GHS implementation in Singapore on the Workplace Safety and Health Council’s website www.wshc.sg/ghs

Singapore Chemical Industry Council is organising a set of GHS courses. The next course on classification and labelling of chemicals is on 27-28 January 2015. For more details, please see here.

If you are interested in a company specific GHS course, please contact

Ms Henriette Christiansen
hc@dhi.com.sg


Biocidal products containing copper still allowed

Despite failing to submit complete dossiers for the use of copper within the relevant deadlines, copper electrodes as an in situ biocidal active substance can still be placed on the EU market. The use of copper electrodes covers the product-types 2, 5 and 11 (disinfectants, drinking water and preservatives for liquid-cooling and processing systems, respectively).

Dispensation until 2017
Ireland, Estonia, Italy, Poland, France, Belgium, the United Kingdom, Germany, Latvia, Finland, Luxembourg, Sweden, Denmark and Malta have been granted dispensation by the European Commission. Consequently, these EU member states may still allow marketing of biocidal products containing copper (EC No 231-159-6; CAS No 7440-50-8) for a number of uses. The dispensation is valid until the end of 2017 provided a dossier is submitted and validated as complete by ECHA by 31 December 2014.

The above-mentioned has been adopted in Commission Decision 2014/395/EU (see page 103).

Following this decision, copper may still be used for various purposes such as preventing growth of organisms in water for a number of uses, including swimming pools, water inlets for offshore oil and gas platforms, other marine and coastal installations, or on ships.

For more information on biocides, please contact

Ann Detmer
ad@dhigroup.com


More accurate calculation of pesticide exposure

A new guidance and calculator tool is an important contribution to safeguarding public health from exposure to pesticides.  With the guidance it is possible to calculate non-dietary exposure with more accuracy than ever before.

It is a working group within the EFSA Panel on Plant Protection Products and their Residues that has prepared the guidance document to ensure a consistent regulatory approach within the EU risk assessment of plant protection products (PPPs). The guidance is designed to assist risk assessors and notifiers/applicants when quantifying potential non-dietary, systemic exposures as part of the regulatory risk assessment of PPPs.

Download the Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products.

If you want to know more about pesticides and risk assessment, please contact:

Ann Detmer
ad@dhigroup.com


DHI in partnership on environmental solutions

On 9 December 2014, the Danish Minister of the Environment, Ms Kirsten Brosbøl, launched a new partnership with the aim to replace chemical substances of concern. The new partnership will assist particularly small and medium-sized companies to find new alternatives to the chemicals they use today.

Substitution of chemicals of concern
DHI is one of the partners. We contribute to the project with methods and tools that will enable companies to identify substances of concern in their product portfolio and to evaluate health and environmental impacts of possible alternatives. Furthermore, we will be responsible for a portal that will convey results from the partnership. It will also be possible to download online courses and to get assistance from researchers with substitution of chemicals.

Besides DHI, partners include the Danish Technological Institute (technical expertise), the British company RPA (economic evaluations) plus the Danish universities in Copenhagen and Aarhus. The Danish Environmental Protection Agency supports the partnership financially for the next four years, including support to green projects. Companies may also apply for subsidies for consultancy.

For more information, please contact

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


Consumer safety

Borderline products - crossing the cosmetics and biocides regulations

Based on the claims made by the producer a product is classified as a cosmetic product or a biocidal product. However, sometimes a product can be both and thus have to comply with both regulations. Such borderline products serve a primary cosmetic purpose but also an equally important biocidal purpose. Dual purpose products will be regulated by the cosmetics legislation with regard to their cosmetic purpose and by the biocides legislation with regard to their biocidal purpose. Such products include sunscreens with jellyfish repellent effect or sunscreens with insect repellent effect.

Claims may be a strong indication of the intended product function and of consumer perception and will therefore help to form a preliminary assumption on the regulatory status of the product. However, to get a full picture it is necessary to assess all the characteristics of the product, including claims, its overall presentation, use and composition. This must be done on a case-by-case basis before making a final decision.

Guidance documents on borderline products
The European Commission has issued a number of documents to help producers define which products should comply with both regulations. These can be assessed through the Commission homepage

Furthermore, a draft document published on CIRCABC* offers further information.

How to decide which regulation
The practical approach to find out which regulation applies in relation to a borderline product could be as follows: The company responsible for placing the product on the market should approach the public authority in question. On a case-by-case approach and taking into account claims, presentation and ingredients of the product, the authority will decide whether it is a cosmetic product or not. In cases of disagreement only the Court of Justice of the European Union can give authoritative interpretations of the contents of Union law.

If you want an independent opinion on a borderline product or assistance in contacting the authorities, please contact

Estelle Giovalle
egi@dhigroup.com
Tel +45 4516 9205

*The European Commission’s Communication and Information Resource Centre for Administrations, Businesses and Citizens.


Interface between REACH and Cosmetics regulations

According to the EU Cosmetics Regulation, the marketing and animal testing bans for cosmetic products and ingredients came fully into force in March 2013. However, to comply with the REACH regulation, registrants of substances that are used in cosmetics may have to perform animal testing.

The difference in the interface between REACH and the Cosmetics regulations can be described as follows:

  1. Registrants of substances that are exclusively used in cosmetics may not perform animal testing to meet the information requirements of the REACH human health endpoints. The exception is any testing required to assess the risks from exposure to workers (persons who are actively involved in a particular activity of a production or manufacturing site).
  2. Registrants of substances that are also used for non-cosmetic uses are permitted to perform animal testing, as a last resort, for all human health endpoints.
  3. All registrants (whether or not they only use the substance for cosmetic purposes) are permitted to perform animal testing, as a last resort, for all environmental endpoints.

ECHA has published a factsheet on the Interface between REACH and Cosmetics regulations.

If you want to know more about how to meet the requirements of both REACH and the Cosmetics regulations, please contact

Estelle Giovalle
egi@dhigroup.com
Tel +45 4516 9205


Extended deadlines for Danish approval of drinking water installations

In Denmark rules apply to approval of drinking water installations. In April 2013 the former VA-approval scheme ceased. Since then building components that come into contact with drinking water must be approved under the GDV approval scheme*. Approvals for building components approved under the VA-approval are valid as long as their VA-approval is valid.  Until now only few components have obtained a GDV-approval. However, many VA-approvals will expire at the end of 2014. These include taps, faucets, fittings, tubes and filters.

VA-approvals extended until 1 October 2015
In consequence, the VA-approvals have been extended until 1 October 2015. If your product already has an approval date beyond 1 October 2015, this approval date is still valid. The extension date came into force on 15 November 2014 and includes VA-approvals issued before 1 April 2013. Please note, that the extension does not cover VA-approvals issued only for physical or mechanical parameters as these are not within the scope of the GDV-approval.

New GDV-executive order expected by April 2015
In connection with our toxicological assessments of drinking water installations and their chemical substances, we are in close contact with the Danish authorities. One requirement that many building components of brass have not been able to meet is the requirement concerning migration of “other metals”. Metals such as aluminium, antimony, chromium, cobalt, manganese, mercury and molybdenum may migrate from brass and in concentrations exceeding the maximum limit values. In a draft proposal to a new executive order, the Danish Energy Agency proposes to remove the requirement for testing of “other metals” If the proposal is adopted, in the future brass will only have to be tested for lead, cadmium and nickel. This means that more building components will obtain a GDV-approval.

Useful links

For more information, you are also welcome to contact

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

*GDV: Godkendt til DrikkeVand (Approved for Drinking Water)


Chemicals in textiles

The Swedish Chemicals Agency has compiled information about the risks to human health and the environment from hazardous substances in textile articles. Although large quantities of substances are used in textile production, the knowledge of the chemical content in textiles is poor. Comprehensive information about the identity of the substances and their hazardous properties is needed to assess the risks related to the use of the textile articles placed on the EU market.

Textile substances may be sensitising at skin contact
To produce 1 kg of cotton t-shirts, 3 kg of chemicals is used.  During washing many chemical residues end up in the environment. Another problem pointed out in the report is that several chemicals used in textiles are sensitising at skin contact. In cosmetic products many sensitising fragrances are banned through legislation, whereas chemicals used in other consumer products with direct skin contact such as clothes are not directly targeted through the REACH regulation or other EU legislations.

The overall conclusion of the report is that the EU legislation should be extended to cover risks from substances in textile articles, and the requirement for information from suppliers of substances in textile articles should be further developed. Moreover, there is a need for further research in this field.

Read the report Chemicals in textiles here.

If you want to know more about chemicals in textiles, please contact

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


Life science

Dry skin less resistant to chemicals exposure

Up to 10% of Europeans and 5% of Asians suffer from a genetic mutation which makes their skin more porous. The mutation is common among people suffering from dry skin or eczema. A new Danish research study proves that people with this genetic mutation are also more prone to uptake of hazardous chemicals via the skin.

In the study the 7.5%  young Danish men carrying the genetic mutation had a 33% higher urinary concentration of phthalate metabolites due to increased transepidermal absorption. The researches only investigated the uptake of phthalates, but studies of other classes of chemicals are expected. In addition, studies will be carried out of other populations including women and children.

Absence of filaggrin
The genetic mutation is due to a lack of filaggrin, a protein vital for the epidermis. Filaggrin binds moisture in the skin and makes up 50% of the skin’s natural moisture barrier. The lack of filaggrin makes the skin more porous and susceptible to uptake of chemical substances. One important source of exposure is skin care products. However, the results also proved that phthalates in the air and from dust are absorbed through skin and contribute to chemical exposure.

The Danish study is published in Environmental Health Perspectives.

For more information on exposure to chemicals, please contact

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


ECHA review of alternatives to animal testing

In September ECHA published a report on alternative methods to animal testing produced by the European Commission’s Joint Research Centre. It is an up-to-date review with easily accessible information on alternatives to animal testing. This report is relevant to everyone working with testing proposals and registration/development of chemicals, biocidal products, cosmetics and pharmaceuticals.

The report can be downloaded here

If you want to discuss testing strategies, please contact

Ann Detmer
ad@dhigroup.com


Food

Microplastic contaminants in beer

German researches have investigated if microplastics can be established in products for human consumption. The team chose to examine popular German beer brands and found microplastics in all the investigated beer samples.

The three main sources of contamination are:

  • Atmospheric  - particles are emitted from various indoor sources and via infiltration of contaminated outdoor air
  • From materials used in the production process such as accessory agents or impurities from cracked filters or separation from container walls
  • Impurities from the cleaning process

Although the researchers did not find the results alarming, the findings indicate that the human environment is contaminated by micro-sized synthetic polymers. It may be overcome, at least in part, by applying principles of hygienic industrial design.

Read the full article Synthetic particles as contaminants in German beers

Microplastic is defined as smaller than 5 mm in size and made of synthetic polymers.

For more information on food contamination, please contact

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


Meet us

Conference on R&D of Disinfectants, Detergents & Cleaning Products, Germany
Torben Madsen and Michael Fink will attend the above R&D conference in Berlin on 10 and 11 February 2015.

2015 Aquatic Sciences Meeting, Spain
Louise Schlüter and Merete Allerup will attend the above conference in Granada on 22 – 27 February 2015. Drop by our stand to learn more about how to use pigment standards for plankton investigations.

Global Supply Chain Workshop 2015, Brussels
Hülya Genc-Fuhrman and Torben Madsen will attend the above conference in Brussels on 25-26 February 2015.


Courses

GHS Classification and Labelling of Chemicals, Singapore 27-28 January 2015. The course is hosted by Singapore Chemical Industry Council (SCIC). Course instructor is Ms Henriette Christiansen, DHI


Contact

DHI | Agern Allé 5 | 2970 Hørsholm | Denmark
Tel: +45 4516 9200 | Fax: +45 4516 9292 | www.tox.dhigroup.com



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