News about Environment
and Toxicology

September 2016




Chemicals

Reference doses for industrial use of cobalt salts

Cobalt salts are used widely throughout industry as industrial catalysts, in pigments, dyes, inks, as additives to soils and animal feeds, and in dietary supplements. ECHA’s Committee for Risk Assessment (RAC) has concluded that five water soluble cobalt salts should be considered genotoxic carcinogens and are to be assessed using a non-threshold approach.

This is the result of a study of the five cobalt salts identified as substances of very high concern (SVHC) under the EU REACH Regulation and consequently placed on the candidate list for authorisation. The five substances are cobalt(II) sulphate, cobalt dichloride, cobalt(II) dinitrate, cobalt(II) carbonate and cobalt(II) diacetate.

As sufficient documentation was lacking to identify thresholds, a non-threshold approach is considered the most cautious for assessing genotoxic carcinogens. Using the non-threshold approach, the following dose-response relationships have been derived:

  • Worker exposure (8 h/d): Excess risk = exposure level (mg Co/m3) x 1.05 (mg Co/m3)-1
  • General population exposure (24 h/d): Excess risk = exposure level (mg Co/m3) x 5.88 (mg Co/m3)-1

For more details, please consult:

ECHA announcement: Establishing a Reference Dose Response Relationship for Carcinogenicity of Five Cobalt Salts

ECHA project SR 23: Support to the assessment of remaining cancer risks related to the industrial use of cobalt salts in the context of chemical risk management procedures under REACH

DHI performed the assessment of the five cobalt salts for ECHA. Based on the assessment results, RAC concluded that the water soluble cobalt salts should be considered genotoxic carcinogens.

For further information, please contact the co-authors of the ECHA project:

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

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


Grouping of brominated flame retardants

Regulation of individual substances is time-consuming. Consequently, grouping of substances with similar chemical structures may prove advantageous.

In a Danish project, a series of brominated flame retardants have been grouped in order to make a group approach for evaluating the mutagenic and carcinogenic effects by the use of QSAR tools.

Overall, brominated flame retardants are used in many products to reduce flammability, for instance in computers and televisions. Other studies, in which also DHI has been involved, indicate that many of the brominated substances may be of concern regarding endocrine effects and reprotoxic effects. Furthermore, the substances are suspected of being bioaccumulative.

For more details, please consult the report  Category approach for selected brominated flame retardants

For queries concerning BFRs, please contact:

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


Adaptations to CLP Regulation

The 8th adaptation to the CLP Regulation was published in early summer. Below a brief outline of some of the main changes.

The allocation of precautionary statements to many physical hazard categories has been changed, and aerosols should be considered for classification as Aerosol category 1 or 2 if they contain ≥ 1% w/w flammable gases, liquids or solids.

The chapter on skin corrosion/irritation (Chap. 3.2) has been entirely substituted. Some of the more significant changes include detailed explanation of classification based on tiered approach, and clarification on classification of corrosive substances and mixtures when data are not sufficient for sub-categorisation.

Likewise, the chapter on eye damage/irritation (Chap. 3.3) is entirely substituted.

Please refer to the 8th adaptation to CLP for complete details and new label elements.

For more details on the 8th adaptation, you are also welcome to contact:

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


Updated harmonised classifications for 48 substancess

New or updated classifications for 48 substances have to be applied by 1 March 2018 at the latest. This is evident from the 9th adaptation to the CLP Regulation.

If you are in the process of updating product labelling or safety data sheets or will be doing so in the near future, we recommend checking if any of the products will be affected by the 9th adaptation.

Of the 48 substances included in the 9th adaptation, 22 substances already are on the existing list of harmonised classifications while harmonised classifications have been assigned to 26 substances not previously on the list.

View the 9th adaptation containing annex of the 48 substances here.

For more information about the CLP Regulation and classifications, please contact

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


Environment

Evaluation of toluene in drinking water and soil

Toluene is an organic solvent and is a constituent of various fuel streams from petrochemical refining.  Thus, toluene is a common chemical constituent in the many cases where soil has been contaminated with various types of petrochemical fuels or solvents.

The purpose of a project on evaluation of toluene was to provide background documentation for the Danish Environmental Protection Agency to establish health based quality criteria for the content of toluene in soil and drinking water. The report proposed the following new quality criteria:

  • Drinking water: 25 μg/l (for protection against odour from toluene)
  • Soil: 0.4 mg/m3 (evaporation criterion)

 

As toluene has a pungent odour, it should be noted that odour, and not the toxicological effects, was found to be the limiting factor for toluene content in drinking water and soil.

More detailed information is available in the report Toluene, Evaluation of health hazards and proposal of health based quality criteria for drinking water and soil. The project was carried out by DHI on behalf of the Danish EPA.

For more information on toluene, please contact

Poul Bo Larsen
pbl@dhigroup.com
Tel 4516 9478


Life science

New EU regulation on medical devices

The EU has agreed on new draft regulations on medical devices and in vitro diagnostic medical devices, which may pose new challenges for manufacturers in terms of their responsibilities for the follow-up on quality, performance and safety.

The aim is to ensure safe products and to facilitate marketing of innovative health care solutions for the benefit of the patients. The new rules are expected to apply from 2019 (medical devices) and 2021 (in vitro diagnostic medical devices), respectively.

Safety of medical devices will be ensured by strengthening the rules on placing devices on the market and by reinforcing surveillance. This includes unannounced factory inspections by responsible notified bodies.

Unique identification number
A central database will be set up to provide patients, healthcare professionals and the public with comprehensive information on products available on the EU market. This will ensure traceability of a product from factory to patient.

More in-depth details are available on the European Council's webpage, including pdf’s of the agreed regulations on medical devices and in vitro diagnostic medical devices.

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

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

Torben W. Schou
tws@dhigroup.com
Tel +45 4516 9509


Safety of tattoos

The European Chemicals Agency, ECHA, is to prepare a proposal for joint EU legislation on tattoos and permanent make-up.

The European Commission’s Joint Research Centre (JRC) has recently published a report on the safety of tattoos and permanent make-up. Based on the report and following a request from the European Commission, ECHA is to decide if there is a need to prepare a possible restriction proposal within the framework of the REACH regulation.

Possible safety issues
Currently, there is no specific EU legislation on tattoos or permanent make-up products. They fall, like any other consumer products, under the Directive on General Product Safety requiring that only safe products may be placed on the market. Since the colours used are not specifically made for use as tattoo colours, specifications and purity are usually not adapted to this use and impurities and degradation products can be a safety issue.

View the final report from JRC on Safety of tattoos and permanent make-up.

It is estimated that 12% of the Europeans (60 million people) and up to 24% of the US citizens have a tattoe.

For more information, please contact:

Ann Detmer
ad@dhigroup.com


Food

German positive list of printing inks for food contact materials

The German food authorities has issued a draft regulation applying to printed food contact materials and articles. The draft regulation includes a list of substances permitted for use in printing inks for printing food contact materials and articles. Only substances for which a risk assessment or adequate toxicological data are available are included.

Substances not on the list may still be used for food contact materials provided that the printing does not come into direct contact with the foodstuff and that substances do not migrate to foodstuffs from the printing inks.

The draft regulation and positive list are available in German, French and English here.

For more information, please contact

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


Mineral oil findings in dry foods

Testing of dry food products for mineral oil residues revealed contamination of a quarter of the products.

The German branch of the non-profit organisation Foodwatch has tested a total of 446 products for mineral oil contamination. The evaluation showed that 128 products (28.7%) were contaminated with mineral oil aromatic hydrocarbons (MOAH) and 375 products (84.1%) contained mineral oil saturated hydrocarbons (MOSH). The affected products are mostly dry foods such as rice, wheat semolina, noodles, and chocolate packaged in paper or board. Foodwatch now urges the German food authorities to take further action.

The mineral oil residues are mainly caused by leakage of printing ink from the packaging or by using recycled paper and board for packaging.

For more information on food contact materials, please contact:

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


EFSA proposes reduced copper content in animal feed

A proposal from the European Food Safety Authority, EFSA, to modify the amount of copper in animal feed will reduce copper released into the environment and potentially reduce antimicrobial resistance.

EFSA recommends that copper content in complete feed for piglets should not exceed 25 mg per kg (down from 170 mg/kg). The maximum content of copper in complete feed for dairy cows and cattle should be reduced from 35 mg/kg of feed to 30 mg/kg.

The currently authorised upper levels will remain unchanged for other animal groups, except for goats where an increase is recommended.

View EFSA’s Revision of the currently authorised maximum copper content in complete feed

For questions on animal feed, please contact:

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


EU supplementing regulation on food for special purposes

In the European Union, supplementing regulation has been adopted for food for particular purposes. These comprise food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control. The supplementing regulation includes compositional requirements and specific requirements on food information.

Dates of application
The requirements are adopted with the EU Commission Delegated Regulation (EU) 2016/128 of 25 September 2015 supplementing Regulation (EU) No 609/2013. Regulation No 609/2013 was applied on 20 July 2016. The delegated regulation (EU) 2016/128 will apply from 21 February 2019 with the exception of food for special medical purposes developed to satisfy the nutritional requirements of infants, which will apply from 22 February 2020.

View the regulations here:

The supplementing regulation does not cover food for athletes and young-child formulae that must meet other EU requirements.

For more information on food for special purposes, please contact:

Ann Detmer
ad@dhigroup.com


Meet us at

Copenhagen Chemicals Summit 2016 - Denmark
Senior Consultant Anne Rathmann Pedersen has been invited to speak about Chemicals and Sustainable Construction at the Copenhagen Chemicals Summit taking place on 28-29 September in Copenhagen.

European Symposium on The New Agreed Draft Regulations on Medical Devices (RMD2016) - Czech Republic
Scientific Adviser Torben W. Schou will participate in the above symposium in Prague on 7-8 November 2016.

Extractables and Leachables Europe 2016 - Ireland
Senior Toxicologist Helle Buchardt Boyd will present a poster on Addressing Consumer Concerns Regarding Leachables. The conference is held in Dublin on 8-10 November 2016.


Courses

Free webinar: Danish code numbers for paints, fillers, adhesives and similar products – 11 October

Free webinar: Notification of chemical products in Denmark – 22 November
View all our courses here.


Contact

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Please send an e-mail to ves@dhigroup.com – write Subscribe to newsletter or Unsubscribe newsletter in the subject line.


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