News about Environment
and Toxicology

February 2015




Chemicals and biocides

Easier authorisation for authorisation list substances

The European Commission and the European Chemicals Agency, ECHA, will make it easier to obtain an authorisation to use the currently 31 substances on the Authorisation List.

The Commission will introduce a simplified application procedure to assist the many downstream users that cannot substitute the substances on the list. This may include lower fees for low tonnage applications and standard templates for applications. The latest recommendations for inclusion on the Authorisation List from 1 December 2014 contained 22 substances. The final decisions are still pending.

At a meeting in Helsinki on 10 and 11 February, ECHA and the Commission said they expect more substances to appear on the authorisation list, but also that it should be easier and less costly for future applicants.

For more information, please contact

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


Get ready for REACH 2018

ECHA has published new information on their website to help industry comply with the next REACH registration deadline in May 2018. As the deadline obligates industry to submit a registration dossier for substances produced within the European Economic Area (EEA) or imported to the EEA above 1 t/year, ECHA anticipates approx. 70,000 dossiers to be submitted.

Substance identification is vital
When preparing REACH registration dossiers, accurate and full substance identification as required by ECHA is the first vital step. Correct substance identification is paramount for the rest of the dossier content and actions to be taken, such as data-gap analysis, read across, and buying a Letter of Access (LoA). An impurity not identified correctly from the beginning may change the substance identification, or the data presented in the dossier may not represent the actual substance to be registered, which in turn may lead to a dossier compliance failure.

It must be expected that the preparation of the large number of REACH registration dossiers will put great pressure on both testing laboratories and service providers. In this context industry is encouraged to act promptly and not wait for the deadline for the dossier submission. Furthermore, ECHA's REACH IT system will probably be challenged as well to accommodate the large number of submissions.

More information from ECHA on REACH 2018

For more information, please contact

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


Canada implements GHS

On 11 February 2015, the Hazardous Products Regulations (HPR) has been published in the Canada Gazette, the official newspaper of the Government of Canada. Together with the amended Hazardous Products Act (HPA), the HPR constitutes the Workplace Hazardous Materials Information System (WHMIS 2015) that sets the requirements for hazard classification and communication at the workplace based on GHS.

Highlights are listed below:

  • The following building blocks are not implemented:
  • Chemically unstable gases, all categories;
  • Aerosol, category 3 (non-flammable aerosols);
  • Acute toxicity, category 5;
  • Skin corrosion/irritation, category 3;
  • Aspiration hazard, category 2;
  • Aquatic acute, all categories;
  • Aquatic chronic, all categories;
  • Ozone, category 1.

Six new hazard categories (out of the scope of GHS) have been implemented:

  • Combustible dusts;
  • Simple asphyxiants;
  • Pyrophoric gases;
  • Physical hazards not otherwise classified;
  • Biohazardous Infectious Materials;
  • Health hazards not otherwise classified.

The provisions of the HPR will be obligatory for manufacturers and importers as from 1 June 2017, and by 1 December 2018 for all suppliers and employers.

A transition period, divided in three phases, has been granted. During the transition period it is possible to comply either with the old system (CPR) or the new one. It is not allowed to use a combination of both systems. The three phases are summarised in the table below:


Phase

Time period

Suppliers

Employers

Manufacturers and Importers

Distributors

1

Entry into force: 31 May 2017

CPR or HPR

CPR or HPR

Regional level

2

1 June 2017 – 31 May 2018

HPR

CPR or HPR

CPR or HPR

3

1 June 2018 – 30 November 2018

HPR

HPR

CPR or HPR

Stay updated on GHS implementation in Canada and worldwide on http://ghs.dhigroup.com/

You are also welcome to contact:

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


CLP and the Danish Product Registry

By 1 June 2015 all chemical products must be classified and labelled according to the CLP regulation. If you have products that have been notified with the Danish Product Registry, it is your responsibility that the notifications are updated with the new classifications and labelling.

As a rule, the product will keep its product registration number if the chemical composition of the product and other information is unchanged.  For more information on the Danish Product Registry, click here.

For queries about CLP and product registration, please contact

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


No extension of Article 95 deadline for biocides

In all probability, the September 2015 deadline to meet the requirements of Article 95 in the EU biocidal regulation will be a hot issue at the forthcoming meeting of the competent authorities on biocides in March.

Although industry associations have sought to argue for an extension, it is unlikely that this will be obliged by the EU. However, official guidance documents are expected by the end of February, e.g. on data sharing and letters of access.

Article 95 of the Biocidal Products Regulation (BPR) stipulates that as of 1 September 2015, biocidal products can only be marketed in the EU if they contain active substances from the list of approved suppliers (manufacturers, importers and formulators). Formulators (product suppliers) are worried that it is unclear when they will know for certain if their supplier is on the list.

For more information on biocidal regulation, please contact

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


Consultation on disinfectant PHMB

France has submitted a proposal to ECHA, the European Chemicals Agency, for the substance polyhexamethylene biguanide (PHMB) to be considered as a candidate for substitution.

Due to its antiseptic properties, PHMB is a widely used disinfectant and preservative in cosmetics and wound-healing products, in cleaning agents in the food and feed industry, and in industrial processes.

France argues that PHMB is very persistent and toxic. Contrary to this, a 2014 scientific study initiated by the European Commission was inconclusive as to the toxic effects of the substance when used in cosmetics.

The consultation closes on 10 April 2015.

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


Biocides and antibiotic resistance

A new research project will examine the risk of developing and spreading resistance in bacteria when using biocidal substances in disinfectants.

The development of resistant microorganisms is well-known due to the widespread use of antibiotics. However, the issue is also relevant concerning anti-microbial biocides used in disinfectants. Tests have shown that bacteria treated with non-lethal doses of biocides may develop resistance to antibiotics without developing resistance to the active biocidal substance.

Common pathogens to be investigated
The project will investigate the effects of three different biocides (benzalkonium chloride, hydrogen peroxide and nanosilver) on two important pathogenic bacteria. Both these bacteria have been the focus of much media attention due to serious outbreaks of infections, Listeria monocytogenes (food infection) and Staphylococcus aureus (MRSA infection), respectively.

One of the purposes is to develop a modelling tool to assess how and how quickly resistant genes spread in hospital environments. Hopefully, the results of the project will also make it easier to screen biocidal substances for the risk of developing resistance.

The project is carried out by DHI in collaboration with the University of Copenhagen and is supported by the Danish Environmental Protection Agency. It is expected to be completed in 2016.

For more information, please contact

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


Environment

New EU GMO law with increased flexibility

The European Parliament has voted for providing member states with opt-out tools to restrict the cultivation of already EU authorised genetically modified organisms (GMOs) on their territory. A decision to ban GMOs can be based on reasons other than the risk of health and the environment. The legislation is expected to be endorsed by the European Council soon, allowing the member states to start exercising their extended capacities to decide on GMO cultivation as from spring this year.

For more information, please refer to the press release Parliament backs GMO opt-out for EU member states

For further information on GMOs and crops, please contact

Ann Detmer
ad@dhigroup.com


Bioavailability of metals in freshwater

A recent study has tested the applicability of available tools for assessing the bioavailability of metals in freshwater. The tools have been assessed for use under Danish conditions as the revised EU environmental quality standards (EQS) for nickel (Ni) and lead (Pb) must be implemented in Danish legislation by September 2015. Accounting for bioavailability in the regulation of metals in freshwaters is a relatively novel regulatory approach and represents a considerable change to existing ways of working with risk assessment of metals.

The EQS are of interest both for manufacturing companies discharging wastewater and local authorities granting the discharge permissions.

Models for assessment of bioavailability
The bioavailable fraction indicates the fraction of the dissolved concentration of substance, which is freely available for uptake in aquatic organisms. Parameters that are important for the uptake of copper, nickel and zinc are pH, hardness of the water as well as presence of organic material. The Danish Nature Agency initiated a study on the applicability of two user-friendly tools; Bio-Met and M-BAT. The tools were applied for assessing the bioavailability of copper (Cu), nickel (Ni) and zinc (Zn) in Danish freshwater.

Conclusion
Both Bio-Met and M-BAT proved to be applicable. Furthermore, it was concluded that physical-chemical characteristics (pH, calcium concentration and dissolved organic material) significantly influence the bioavailability of these metals and consequently the compliance with the environmental requirements.

The study Bioavailability modelling of three metals in Danish freshwater systems was carried out by DHI on behalf of the Danish Nature Agency.

For questions concerning requirements on the water environment, please contact

Tina Slothuus
tsl@dhigroup.com
Tel +45 4516 9547


Life science

Minor absorption of nano titanium dioxide

A scientific study indicates that only minor amounts of titanium dioxide nanoparticles are absorbed into the body upon ingestion.

The purpose of the study was to assess the health risks of titanium dioxide nanoparticles, including risks in connection with the work environment. The results indicate that minor absorption occurs from the gastrointestinal tract, but to a very limited extent. On the other hand, the elimination of the nanoparticles from the body is very slow and in the long run may result in potential tissue accumulation.

Titanium dioxide is a white pigment used in thousands of products, including foodstuff (E number E171) and cosmetics such as sun screen and toothpaste. The substance is available in different types, some of them only as nanoparticles.

The study Tissue distribution and elimination after oral and intravenous administration of different titanium dioxide nanoparticles in rats has been published by Particle and Fibre Toxicology (open access).

For questions on substances and human toxicology, please contact

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


Food

Belgium takes lead on insects as food

In 2014 the Belgian food authorities published a list of 10 insect species that can be used as food in Belgium. The insects can be used following specific conditions until the European status of insect use in food has been clarified by the European Commission.

Currently, there is legal uncertainty about including entire insects and their preparations (such as worm pasta) within the scope of the novel food regulation. However, whole insects will probably be included in the coming revision of the regulation.

Thus, if you wish to use insects for food you need to prepare a strategy to reach market, including preparing a novel food dossier.

Further reading:

For assistance with novel food regulation, please contact

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


Arsenic in trisodium citrate from China

Since July 2014 an increasing number of notifications in the European Commission's Rapid Alert System for Food and Feed (RASFF) have been published regarding increased arsenic levels in Trisodium citrate dihydrate (TSC). The TSC has been imported from China into several EU countries.

TSC (E number E331) is widely used in foods, beverages and various technical applications mainly as buffering, sequestering or as an emulsifying agent.

TSC is a tribasic salt of citric acid. It is produced by complete neutralisation of citric acid with high purity sodium hydroxide or carbonate and subsequent crystallisation. TSC occurs as white granular crystals or as a white crystalline powder with a pleasant, salty taste. It is slightly deliquescent in moist air, freely soluble in water and practically insoluble in ethanol (96%).

For more information, please contact

Ann Detmer
ad@dhigroup.com


European outbreak of hepatitis A virus not solved

No specific country or processor has been identified in connection with the European-wide outbreak of hepatitis A virus in 2013. The outbreak can be linked to eating frozen berries predominantly from Poland or Bulgaria. These countries are, however, also the main producers of frozen berries (blackberries, raspberries and red currants). As no single source of contamination has been identified correlated to all cases, it can be concluded that this is a continuing problem not yet solved. Compliance with Good Hygiene Practice, Good Manufacturing Practice and Good Agricultural Practice is recommended for countries producing berries for freezing.

Consumers are recommended to heat-treat all frozen berries before direct consumption or use in food. Caterers, restaurants and bakeries should not use frozen berries for decoration or as ingredients without prior heat treatment.

You can read more about the tracings in a report from EFSA, the European Food Safety Authority.
For more information on food toxicology and food safety, please contact

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


Meet us

The 19th ICIS World Base Oils & Lubricants Conference, London
Anne Rathmann Pedersen has been invited to give a talk entitled “Understanding REACH and what it means for base oils and lubricants” at the above conference in London on 19-20 February

2015 Aquatic Sciences Meeting, Spain
Louise Schlüter and Merete Allerup will attend the above conference in Granada, Spain on 22–24 February 2015. Drop by their stand to learn more about how to use pigment standards for plankton investigations.

Copenhagen Food Fair, Denmark
Helle Buchardt Boyd participates in the food fair, which takes place in Copenhagen on 22–24 February.

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

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


Contact

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



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