News about Environment
and Toxicology

July 2015




Chemicals and biocides

Period of grace after 1 September biocide deadline?

The European Commission has openly suggested that the national enforcement authorities should not penalise companies that are not fully compliant with the Article 95 obligations after the 1 September deadline. From 1 September 2015 biocidal products can only be marketed in the EU if they contain active substances from approved suppliers that are listed on the so-called Article 95 list of the Biocidal Products Regulation.

It is estimated that a majority of companies have difficulties in meeting this deadline – or are simply not aware that they fall within the scope of Article 95. The Commission proposes that member states use the period after 1 September to raise awareness of the obligations and request companies to prove they will comply with the regulation within a given period of time.

Although companies should not be penalised for not meeting the 1 September deadline, each EU member state must still ensure that the provisions of Article 95 are met.

For more information, please consult

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


Stricter label requirements for biocide treated articles

The European Commission has put forward a new proposal for labelling of treated articles. The proposal is an extension of the present requirements and will impose new requirements for labelling of treated articles containing approved active substances that are:

  • skin sensitisers
  • respiratory sensitisers
  • very persistent and/or very bioaccumulative
  • substances of very high concern (SVHC)

All treated articles containing any of the above must have a label stating that it includes a biocidal product as well as the names of all active substances in the product. The decision goes beyond the labelling requirements of the CLP Regulation. Consequently, it will impose additional labelling requirements on companies, whereas it will safeguard consumer protection.

Treated articles include leather shoes treated with a fungicide, clothing with antimicrobial treatment, cleaning agents and paints containing a preservative.

For more information on biocides and active substances, please contact

Kirsten Bogtoft Møller
kim@dhigroup.com
Tel: +45 4516 9054


Matches – article or chemical?

Are matches an article or a chemical? The matter was settled after some correspondence with the Danish Environmental Protection Agency and ECHA: matches are a combination of an article and a chemical mixture. The wood is an article but the sulphur point is a chemical mixture.

Consequently, if you sell matches you should be aware that they must comply with the CLP regulation on classification and labelling. Moreover, a safety data sheet may be required if the matches are sold to professionals.

For more information, please contact

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


Useful tips on REACH and the Authorisation List

An important aim of the European REACH Regulation is to phase out substances of very high concern (SVHC substances). Phase-out substances are placed on the Authorisation List and companies are well advised to keep a watchful eye on this list. What can you do if a substance is subject to authorisation? And is it possible to influence whether a substance is placed on the Authorisation List or not?

Authorisation process may be simplified
If a substance is included on the Authorisation List, you must apply for authorisation to continue to use the substance, unless you can substitute it by a less hazardous substance. So far, it is mainly very large companies or consortia that have applied for authorisation of substances from the Authorisation List. However, also many downstream users are expected to apply for authorisation and can expect a more simple process as a single company. Both preparation of applications by the applicants and the processing by ECHA have been very time-consuming and demanding. As a result, the European Commission is considering ways of simplifying the authorisation process.

Applying for authorisation – pros and cons
Before you apply for authorisation of a substance you have to decide whether you want to apply on your own, or if you want to be covered by an authorisation by your substance supplier. For small and medium-sized companies the easiest solution is to be included in a supplier’s application. If you choose this option, however, you bind yourself to a specific supplier. Consequently, it might be an advantage to embark on preparing your own application and not be reliant on the supplier obtaining authorisation and getting a kind of supplier monopoly. It is also important to be aware of the deadline for applications as you only have one chance for making an application. ECHA sets an approval deadline for each substance. After this date it is not possible to apply for authorisation.

Alternatives to the Authorisation List
If you want to influence whether a substance becomes subject to authorisation, you should keep a close eye on ECHA´s public consultations when substances are proposed to be included on the Authorisation List. It is important for companies to inform how a proposed substance is used and for which purposes and also to inform on safe handling and use. Thus the Commission may decide to establish other regulatory measures rather than including the substance on the Authorisation List.

For more information, please consult

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


More lead and phthalate substances proposed for Authorisation List

At the moment 22 substances are listed for inclusion on the REACH Authorisation List. During the summer ECHA is expected to announce 19 of these substances for inclusion on the list.  These include lead substances, coal tar pitch, four boron substances and seven phthalates.

An additional three lead substances are recommended for the Authorisation List. They await further evaluation before a final decision on inclusion can be made.

View the 22 recommended substances on ECHA’s homepage, here.

For more information, please contact

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


See you in Copenhagen at the Nordic REACH Conference

The final programme for the Nordic REACH Conference is now ready. On 23 and 24 September speakers from ECHA and authorities in Germany, Norway and Denmark as well as industry and trade associations will discuss the forthcoming deadline in 2018.

As a participant you will also have plenty of opportunity to discuss with the speakers and network with peers in different organisations.

View the final programme here. For registration, please click here.

For more information:

Vibeke Ewald Salmon
ves@dhigroup.com
Tel: +45 4516 9144


Food

Maximum levels for inorganic arsenic in rice

Arsenic occurs naturally in earth and is absorbed through plant roots to a various extent. Inorganic arsenic is classified as carcinogenic and the European Commission has decided to introduce maximum levels for inorganic arsenic in rice and rice products.

Dependent on diet composition, rice is the most important contributor of inorganic arsenic in food. White (milled) rice usually contains 0.1 mg inorganic arsenic per kilo, however, the content may be twice this amount. Brown rice (whole-grain rice) usually contains higher levels as the concentration of arsenic is higher in the outer layers. Rice products such as rice flakes and rice cakes also contain high levels of arsenic.

Limit values from 1 January 2016
There is no danger of acute poisoning. Consumption of arsenic over a long period of time, however, may lead to skin changes, vascular and nerve damage and reproductive toxicity, as well as contribute to cardiovascular problems. Moreover, inorganic arsenic is classified as carcinogenic.  To date, it has not been possible to derive a safe intake quantity.

The maximum limit for inorganic arsenic is expected to be introduced by 1 January 2016 and will include the following categories: non-parboiled milled rice (polished or white rice); parboiled rice and husked rice; rice waffles, rice wafers,  rice crackers and rice cakes; rice destined for the production of food for infants and young children.

The German Federal Institute for Risk Assessment (BfR) has compiled a list of questions and answers on arsenic levels in rice and rice products.

For questions on arsenic in food and the toxicology of arsenic, you may also contact:

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


Botanicals in food

Edible plant parts and their products are popular ingredients in food and dietary supplements. There are, however, some obstacles to overcome before products with plant ingredients can be marketed.

It is common to use health claims on products as it increases the sale. At present, the European Food Safety Authority (EFSA) has more than 2,000 health claim applications on botanicals on hold. It is still possible to use certain claims, but it requires sufficient scientific documentation.

Novel food or not
Many plants will come within the scope of the regulation on novel food, i.e. food that has never been consumed to a significant degree by humans in the EU prior to 1997. If that is the case a comprehensive safety assessment is required. As a result, it may be an advantage to be able to prove that a plant has been consumed to a significant extent in the EU before 1997.  The further we get from the 1997 deadline, the more difficult it gets to obtain the required documentation. There is, however, no indications from the food authorities that they intend to advance the 1997 deadline.

Consequently, if you want to market innovative plant products you should be prepared to do your homework thoroughly.

For more information on plants and novel foods, please contact

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


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