News about Environment
and Toxicology

September 2015




Chemicals and biocides

EU court rules in favour of consumers

In September 2015, The European Court of Justice put an end to a long-lived debate about interpretation of the rules concerning information on substances of very high concern in articles. In a ruling the Court decided in favour of seven European countries against the European Commission.

The REACH Regulation stipulates that if a substance of very high concern (SVHC) is present in a concentration above 0.1% of the mass of an article, the supplier must inform the recipient thereof and also, on request, the consumer. The supplier is obliged to provide information to the consumer within 45 days.

Threshold of 0.1% applies to each article component
Until now, the EU member countries have interpreted the rule differently.  The EU Commission has maintained that the 0.1% threshold applied to the entire article, whereas seven EU countries maintained that the rule should apply to each article incorporated in an entire article.

The Court has now ruled in favour of the latter. Consequently, each part of an article, incorporated as a component in an article, is covered by the regulation to notify and provide information on request. A bicycle is an example of an article, which consists of more components such as handles, seat and pedals.

It should be emphasised that the responsibility to notify and inform of compliance with the 0.1% threshold covers the entire supply chain, including importers of articles.

See the Judgment of the Court here.

For more information on substances of concern, please contact

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


EU authorisation of biocides with one application

EU authorisation of biocides with one application

The European Biocidal Products Regulation (BPR) enables companies to get authorisation for their biocidal products in all EU Member States with just one application. In this way, a Union authorisation allows you to place a product on the entire European market without the need to apply for specific national authorisations.

Where biocidal products have similar conditions of use across the European Union, Union authorisation grants them the same rights and obligations. It is possible to apply for Union authorisation both for a single biocidal product and for a biocidal product family.

Products excluded from Union authorisation
Union authorisation is not possible for all products, however. For products that contain active substances fulfilling the exclusion criteria (for example, substances classified as carcinogenic, mutagenic or toxic for reproduction), Union authorisation cannot be granted. Additionally, products that belong to product-types 14, 15, 17, 20 and 21, which cover, for example, products to control rodents, birds and fish, and antifouling products, are also excluded from Union authorisation.

Benefits
With Union authorisation only one application needs to be prepared and evaluated by one Member State. This will make the process more straightforward and the time needed by authorities to review a dossier will be shorter. Clear deadlines are indicated for each step of the application process which will possibly improve the predictability. 

Uncertainties
Challenges need to be noted nonetheless. Firstly, the overall cost of the Union authorisation. When applying for Union authorisation, you must pay fees both to ECHA and to the evaluating member state's competent authority. ECHA administrative fees cover both the authorisation and the annual fees, however, it is not yet known whether some member states will decide to charge additional annual fees. Therefore, at this point, the overall cost is impossible to estimate and could potentially jeopardise the attraction of Union Authorisation.

Another challenge relates to the workload of the member states. It is not certain yet how Union authorisation will work in practice and if all the deadlines can be kept. While ECHA's deadlines are clear and predictable, the member states struggle with lacking resources and overload. Therefore, there is a little uncertainty concerning the overall timeline that may be off track if there are too many applications. 

For more information, please contact

Beata Farkas
bef@dhigroup.com
Tel: +45 4516 9102


7th adaptation to CLP regulation has come into force

The 7th Adaptation to Technical Progress (ATP) to the European CLP regulation came into force on 13 August 2015 and contains updated classifications on 32 substances. Twelve substances are already on the list of harmonized classifications (CLP Annex VI) while 20 substances are new entries. The Commission Regulation (EU) 2015/1221 was adapted by the European Commission on 24 July 2015.

The new and updated substance classifications must be put to use no later than by 1 January 2017. Download 7th ATP to CLP (EU 2015/1221) here.

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


Increased SDS requirements for non-classified mixtures

On 1 June 2015 the EU requirements for delivering on request a safety data sheet (SDS) for non-classified mixtures were toughened. Until then delivering an SDS on request included non-classified mixtures containing:

  • minimum 1% (0.2% for gaseous mixtures) of a substance classified as hazardous to health or environment
  • minimum 0.1% of a PBT/vPvB substance or a substance included on the EU REACH Candidate List
  • a substance with an EU limit value

As of 1 June 2015 delivering an SDS on request comprises the following non-classified mixtures if they contain

  • minimum 1% (0.2% for gaseous mixtures) of a substance classified as hazardous to health or environment
  • minimum 0.1% of a substance classified as Carc. Cat. 2, Repr. Cat. 1A, 1B and 2, Lact., Skin Sens. 1, Resp. Sens. 1, PBT, vPvB or a substance included on the EU REACH candidate list of substances of very high concern (SVHC)
  • a substance with an EU limit value, irrespective of concentration

Consequently, the requirement covers more mixtures than previously. If you are the supplier of a mixture not previously covered by the rules, please check the composition of your mixture to clarify if you must comply with the new requirements.

For queries concerning SDS on substances and mixtures, please contact

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


GHS Revision 6 introduces new hazards

The 6th revised edition of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) has been published by the United Nations Economic Commission for Europe (UNECE). This revision includes:

  • A new hazard class – desensitised explosives;
  • A new hazard category – pyrophoric gases;
  • A guidance on properties to be indicated in section 9 of a Safety Data Sheet (SDS);
  • An example on labelling of small packaging, and
  • Revised and further rationalised precautionary statements.

So far the 6th edition is only available in hard copy. The electronic copy will be available here.

The amendments are summarised here (pdf, 32 pages).

If you want to know more about the worldwide implementation status of GHS, please visit our free GHS Web Portal.

You are also welcome to contact

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


China issues guidance on Hazardous Chemicals Catalogue 2015

The Chinese State Administration of Work Safety (SAWS) has published the Hazardous Chemicals Catalogue 2015 Implementation Guide.

The guide gives a brief introduction of the implementation rules, and the annex contains the list of hazardous substances and related classifications. The official document and annex (in Chinese) can be downloaded here.

For your information, DHI has developed a GHS classification tool that assists you in classifying your products. Please contact us for more information about this tool and our Chinese SDS phrase library.

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


Free webinar: Notification of chemical products in Denmark

Chemical substances and mixtures placed on the Danish market may be subject to product notification to the Danish Working Environment Authority. Join our free webinar and learn more about which products have to be notified, who are obliged to notify products and what information is required.

Target group: The webinar is in English. It addresses both Danish and international manufacturers, suppliers and importers of chemical products to the professional market in Denmark.

Date: Tuesday 27 October at 3 pm – 3.45 pm (Danish time, UTC +1)

Sign up: If you want to join the webinar, please send an e-mail to Vibeke Salmon: ves@dhigroup.com


Environment

EU restrictions on nonylphenol ethoxylates in textiles

The European Commission has decided to restrict the use of Nonylphenol etoxylat (NPE) in clothes and textiles because of the substance's impact on the environment. The decision is based on a risk assessment by ECHA's Committee for Risk Assessment (RAC) and it is the first time that RAC has proposed restrictions on grounds of the environment.

NPE is mainly used as a detergent or an emulsifying agent in the manufacturing of textiles and there is concern for adverse impact on the aquatic environment. The new restrictions of NPE include concentrations of 0.01% or more (100 mg/kg or 100 ppm). A transitional period of 5 years after entry into force of the restriction is proposed.

The decision was made at a meeting in July 2015 following a proposal from Sweden on the basis of restrictions in Annex XV in the REACH Regulation.

For more detailed information: Background document to the Opinion on the Annex XV dossier proposing restrictions on nonylphenol and nonylphenol ethoxylates (pdf, 441 pages).

Ann Detmer
ad@dhigroup.com


Life science

Updated opinion on DEHP in medical devices

The use of the phthalate DEHP in medical devices and the potential risk for patient exposure to leaching from the devices is the main focus of a 2015 opinion from the European Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). The previous opinion was from 2008.

SCENIHR concludes that patients, particularly neonates and infants, are at risk of high exposure. Furthermore, evidence suggests that DEHP causes the most severe reproductive toxicity in animal studies. Consequently, the need to develop alternative plasticisers is strong.

Alternative plasticisers are being developed, but more data are needed to better understand their leaching properties, their potential toxicity, as well as the efficacy of the treatment. The SCENIHR assessment also includes information on available plasticisers as well as some proposed alternatives to DEHP in medical devices.

View the SCENIHR Opinion on The safety of medical devices containing DEHP-plasticized PVC or other plasticizers on neonates and other groups possibly at risk (2015 update) (pdf, 166 pages).

For more information on medical devices, please contact

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


Food

Labelling of allergens is a jungle

The new EU regulation on labelling of food allergens has been in force for less than a year. The rules prescribe that any presence of allergens must be indicated in the ingredients list.  However, a variety of labelling methods are still seen. Some list allergens in the list of ingredients as they are supposed to, some list them in a separate information box (or both) and yet others state “may contain traces of ....”.

Allergens for which labelling is required
At present the following allergens and products hereof must be labelled if they are marketed in the European Union:

  • cereals containing gluten*, crustaceans*, eggs*, fish*, soybeans*, milk*, nuts*, peanuts*, sulphur dioxide and sulphites*, celery, mustard, sesame, lupin and molluscs.

Allergens marked with an * must be labelled worldwide. However, food allergy differs from region to region. Consequently, the list of allergens for which labelling is required may vary according to region. It is the responsibility of the food manufacturer to keep track of allergens from all ingredients.

Difficult for allergy sufferers
The inadvertent transmission of allergenic ingredients from one production to the next poses a specific problem. As a result, many food manufacturers use the phrase “may contain traces of ...”. However, this makes it complicated for allergy sufferers to assess the seriousness of the labelling – does the content constitute a high or just a very small risk? Guidelines are missing as to which criteria to apply in order to use the “May contain traces of ... “ labelling.

Some ingredients may be exempt from labelling if they can be proven to not contain allergens. DHI has experience in documenting and putting together dossiers for obtaining such exemptions

For questions on food allergens, please contact

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


Still room for improvement of compliance declarations

For many years, the Nordic countries have prioritised documentation for food contact materials (FCM). FCM are used in all stages of food production and can be a general source of contamination of food. During 2013-2015 a working group under the Nordic Council of Ministers has conducted a survey of FCM in the Nordic countries.

Two important focus areas were the food establishments' knowledge of the legislation and whether they could provide the mandatory declaration of compliance (DoC) for FCMs. In most cases the DoC was present, but only 45% of the DoCs contained sufficient information.

Furthermore, samples of soft plastic for use in contact with fatty food showed that almost one third of the samples exceeded the permitted content of phthlalates. Especially, DEHP and DBP were found in high amounts in gloves, hoses and conveyor belts. Consequently, the Nordic food authorities will continue to inspect FCMs.

Find more results in the report Nordic project food contact materials, Control of declarations of compliance (DoC).

For more information on food contact materials and declarations of compliance for FCMs, please contact

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


Meet us

Eurotox 2015, Portugal
Helle Buchardt Boyd will attend the 51st Congress of the European Societies of Toxicology on 13 - 16 September in Porto, Portugal. During the congress, Helle will participate in a continuing education course on Thresholds of Toxicological Concern – Basics and Latest Developments.

13th Ballast Water Management Summit, Rotterdam
Torben Madsen and Gitte I. Petersen will attend the above BWMS summit in Rotterdam, The Netherlands, on 21-22 October 2015. Torben has also been invited to speak at the conference and will give a talk on Experience from three years with US type approval testing of Ballast Water Management Systems.

European REACH Congress 2015, Germany
Hülya Genc-Fuhrman participates in the European REACH Congress 2015. The congress takes place in Düsseldorf, Germany, on 24-25 November.


Courses and REACH Conference

See our remaining courses (in Danish) on our website.


Contact

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Tel: +45 4516 9200 | Fax: +45 4516 9292 | www.tox.dhigroup.com



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