News about Environment
and Toxicology

April 2016




Chemicals

Updates from ChemCon on GHS and exposure scenarios

Chemicals regulation worldwide was the topic of ChemCon Europe 2016 in March and almost 250 delegates met to discuss regulatory issues. Below, a few updates from the conference.

Supply chain communication in the EU
The number of exposure scenarios (ES) in the European supply chain is still limited. Consequently, the coordinated enforcement projects REACH-EN-FORCE will focus on generating and communicating exposure scenarios. National inspections are expected across the EU in 2017.

In March, ECHA launched a new website on use maps. A use map informs on the uses of chemicals in a harmonised and structured way and benefit both registrants and downstream users. The website includes templates and guidance documents.

SUMI (Safe Use of Mixtures Information) is a simple 1-2 page format developed for passing safe use information for industrial and professional end users. A SUMI cannot replace the safety data sheet, but provides safe use information on mixtures tailored to the end user.

Current GHS implementations
Speakers from national authorities and industry gave an overview of the worldwide implementation of GHS. Here a selection of countries:

  • In Taiwan, GHS has become mandatory as of 1 January 2016 for all phase-in chemicals. All other chemicals have been granted a one-year transitional period.
  • Argentina has recently implemented GHS and the requirements will be mandatory from 15 April 2016 for substances and from 1 January 2017 for mixtures.
  • Chile implemented GHS with mandatory effect from September 2015.
  • African countries that are members of the Southern African Development Community (SADC) have committed themselves to implement GHS by 2020. However, only a few have launched implementation plans. Botswana is among these, having committed to achieve implementation by August 2017. At the moment, GHS is only implemented in South Africa and Zambia.
  • Russia is still in the process of approving and passing the Technical Regulation on Safety of Chemical Products. Once the regulation has come into force the national Russian standards (known as GOST) on GHS, which are currently voluntary, will become mandatory in Russia and in the Eurasian Economic Union (EAEU) – the single economic market for free movement of goods, people and services that has been a reality since 1 January 2015.

Confidential Business Information (CBI)
CBI is a topic issue for industry and many countries already have systems that allow critical information to be kept confidential. However, it should be noted that the procedures to apply for CBI may be both costly and time consuming.

For more information, please contact our conference delegates:

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

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


Two-year standstill on REACH guidance documents

To allow REACH registrants a period of stability in preparation of the 2018 REACH deadline, ECHA implements a two-year standstill or moratorium on updates to the majority of the guidance documents on registration requirements. This will be effective as of 31 May 2016.

Some aspects of guidance will still be under consultation after 31 May 2016, for instance guidance documents on data sharing and updates related to IT tools. Prior to 31 May, ECHA will inform which documents will be subject to change during the moratorium.

For more information on REACH registrations, please contact:

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


EU harmonises information on emergency health response

Soon the European regulation on Classification, Labelling and Packaging (CLP) will implement new requirements for communicating information on hazardous mixtures to appointed national bodies. The purpose is to provide emergency health response in case of accidents.

According to the draft regulation, importers and downstream users that place hazardous mixtures on the market must submit the following information to the appointed national bodies:

  • Product identifier
  • Details on the company/person responsible for placing the mixture on the market
  • Telephone number for rapid access to additional product information
  • Classification and label elements
  • Toxicological information
  • Information on mixture components (e.g. identifiers, concentrations and classifications)

The information must be provided in an XML format that has just been published on ECHA’s website.

Introducing a Unique Formula Identifier
Together with the new requirements on information provision, the coming adaptation of CLP will introduce the Unique Formula Identifier (UFI). The UFI is a unique alphanumeric code that unambiguously links the submitted information on the composition of a mixture to a specific mixture. The UFI will be generated by companies using an electronic tool provided by ECHA.

Companies must comply with the new requirements from:

  • 1 July 2019: for mixtures for consumer use
  • 1 July 2020: for mixtures for professional use
  • 1 July 2023: for mixtures for industrial use only

For more details on the new requirements, please contact

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


New exposure scenario tool

We have a developed a tool for exposure scenarios and offer free access for companies wanting to try out the prototype of the tool on their own substance mixtures. EScreator, as the tool is called, is based on the Excel spreadsheet and is immediately available.

Exposure scenarios for mixtures
EScreator is designed to assist formulators and down-stream users with preparation of exposure scenarios (ES) for mixtures or implementation of ESs. We developed EScreator to assist any user of chemicals in determining whether the way they use chemicals is safe and in compliance with the ES received for ingoing substances. Moreover, EScreator helps formulators revise and modify ESs for their raw materials into consolidated documents for their products. EScreator is up-to-date with the European CLP regulation on classification of chemical substances.

Scaling of data
In addition, you can use EScreator to extrapolate or interpolate ES information to actual use conditions – and check if use is safe at conditions different from those given in the ES. Finally, EScreator includes the following embedded software tools to estimate human or environmental exposure: EUSES, Ecetoc, EKMG, StoffenManager and ConsExpo.

EScreator is an expert tool and you need to have some knowledge of exposure scenarios.

If you are interested in testing EScreator, please contact Jens Tørsløv for a demonstration:

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


US guidance document on hazard classification

The United States Occupational Safety & Health Administration (OSHA) has published a Hazard Classification Guidance for Manufacturers, Importers and Employers. The new guidance is designed to help manufacturers and importers of chemicals to identify chemical hazards and to classify these hazards so that workers and downstream users can be informed about and better understand the hazards. The guidance includes working examples of classification for both substances and mixtures.

See the Hazard Classification Guidance for Manufacturers, Importers and Employers

DHI classification tool
As part of our chemicals management software tool, ChemManager®, we have developed the expert classification tool ChemClass. With ChemClass you can classify mixtures based on the implementation of GHS in various countries and compare mixture classifications, for instance in the US and the EU. Read more about ChemClass and ChemManager® here.

For more information, you are welcome to contact:

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


Hazard label phrases in Hebrew

We have added Hebrew to our global DHI phrase library and thus we can now offer hazard label phrases in Hebrew. The phrases are taken from a draft revision of standard SI 2302 Dangerous substances and mixtures: Classification, labelling, marking and packaging, which will implement the GHS in Israel.

Through the DHI phrase library we offer more than 4000 phrases for authoring of SDSs in more than 50 markets and languages worldwide, including GHS signal words, hazards and precautionary statements.

For more information on hazard labelling or the DHI phrase library, please contact:

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


Biocides

Labelling of biocidal products during the transitional period in Denmark

All biocidal products on the Danish market must be labelled according to article 69 of the Biocidal Products Regulation (BPR) and according to the CLP regulation. This also includes biocidal products that fall under the transitional period, i.e. products whose active substances are not yet approved under BPR but still under evaluation. Labelling of these products should not be approved by the Danish EPA as it is required for products under the BPR and the Danish authorisation scheme.

National special rules
Furthermore, in Denmark all biocidal products in the transitional period must be registered in the Danish Product Registry. For more information read here.

For more information on biocidal products, please contact

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


EU approval deadline for active substances in treated articles

The deadline to comply with the European Biocidal Products Regulation (BPR) for approval of active substances in treated articles is drawing close.

Apply before 1 September 2016
For treated articles containing active substances not yet approved, an application dossier for the active substance including data on the relevant product-type must be submitted by 1 September 2016. If a dossier is not submitted by this date, or the active substance is not under evaluation for approval, the treated article containing the active substance cannot remain on the European market after 1 March 2017.

Treated articles are products treated with or incorporating biocidal products containing active substances. Examples of articles include paints and detergents containing in-can preservatives, shower curtains and leather goods etc.

For more information on BPR and treated articles, please contact

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


Triclosan banned as active substance in biocidal products

Following a recommendation from the European Biocidal Products Committee (BPC), the EU Commission has decided to ban the use of triclosan in antibacterial hand soap (PT 1). Consequently, triclosan has been eliminated from use in all biocidal products.

The decision is based on the poor efficacy of the substance at low concentrations and on its adverse impact on the environment. The use of triclosan is still permitted as a preservative in some cosmetics products (up to 0.3%), in mouthwash (up to 0.2%) and in medical devices.

The evaluation of triclosan’s REACH registration is ongoing, particularly with regard to its environmental impact.

For questions on approval of biocides or biocidal products, please contact

Ann Detmer
ad@dhigroup.com
Tel +45 4516 9103


Food

Burden of disease of exposure to foodborne hazards

A Danish research group has developed a method to estimate the burden of foodborne acrylamide. The method can be used to make similar estimations of other chemical hazards with representative food-exposure data.

Loss of healthy life years
The researchers used acrylamide (AA) to estimate a burden of disease, i.e. the impact of the chemical on society in terms of mortality, morbidity and disability. AA was chosen as it is a known food-process contaminant and believed to increase the risk of developing cancer for consumers of all age groups. Estimated by the most conservative approach, the researchers concluded that in Denmark, 1.8 healthy life years per 100,000 inhabitants are lost each year due to exposure to AA through foods.

The results of the study are useful for risk management and comparison with burden of disease estimates of other foodborne hazards.

More details of the study is available from Burden of disease of dietary exposure to acrylamide in Denmark, published in Food and Chemical Toxicology, Volume 90, April 2016, Pages 151–159.

For more information on acrylamide and other dietary exposures, please contact:

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


Cosmetics & Life science

EU bans MIT in cosmetics

The preservative MIT will be banned from use in cosmetic leave-on products such as lotions and deodorants from 2017.

Methylisothiazolinone (MIT) is a very allergenic substance and the European Scientific Committee on Consumer Safety (SCCS) has concluded that the substance should not be used in products staying on the skin. The Danish Environmental Protection Agency has pressed for a ban on MIT in cosmetics for several years.

Reduction of concentration in rinse-off products
MIT is still permitted in rinse-off products such as shampoos and shaving foams. A public consultation has just been launched proposing to reduce the maximum concentration in rinse-off products from the current 0.01% to 0.0015%.

Furthermore, the Danish EPA is urging the European Commission to enforce harmonised rules on classification of MIT as allergenic so that other consumer products containing MIT must be labelled if the content is above 0.00015%. MIT is used in paints, glues etc. A vote on MIT classification in EU is expected in 2017.

For more information on MIT and cosmetic products, please contact:

Helle Westphal
hw@dhigroup.com
Tel +45 4516 9012


Phase out of plastic micro particles in cosmetics

Cosmetics Europe, the European trade association, recommends that the use of plastic micro particles in cosmetics be phased out by 2020. The Swedish Chemicals Agency, KEMI, however wants to speed up the process and has recently proposed a national ban from 1 January 2018 on sale of cosmetic products containing plastic micro particles. Micro particles are used in products for exfoliating (scrubs) and toothpastes in particular. When the plastic micro particles are rinsed off, the particles often end up in the aquatic environment.

Substitutes for plastic micro particles
Today various alternatives exist to replace plastic micro particles such as silicate compounds or pellets of wax or hardened fat. Consequently, it is possible to discontinue the use of plastic micro particles. In the USA, a ban on plastic micro particles in cosmetics has also been adopted and has already been implemented in some states.

Plastic micro particles may be found on the list of ingredients as polyethylene, polypropylene, nylon or polymethylmetacrylate.

Read Cosmetics Europe’s Recommendation on solid plastic particles (plastic micro particles) .

Please address queries concerning cosmetics to:

Ann Detmer
ad@dhigroup.com
Tel +45 4516 9103  


Soluble nano-transporters in cosmetics

Nano-transporters are vehicles that improve delivery of active ingredients in cosmetics. Data from both experimental animals and humans suggest that nano-transporters penetrate the skin to a greater extent than insoluble solid nanoparticles and are retained within the dermal layer. The challenge, however, in assessing the dermal absorption of nano-transporters is the lack of studies of detecting the nano-transporter itself after application, as mostly the active ingredients have been studied.

In a comprehensive review of the available literature on nano-enabled technologies for cosmetics, the types and uses of soluble nano-transporters in cosmetics have been examined in order to assess the extent of dermal penetration, systemic absorption and toxicity.

May promote allergic skin conditions
Although data are sparse, the available data indicate that the soluble nano-transporters appear to be of relatively low toxicity. However, they may have an ability to promote or enhance allergic skin conditions and diseases.

For more information, please consult the report Assessment of Nano-enabled Technologies in Cosmetics. The report, including an appraised database summarising the literature of the review, is available on the Danish Environmental Protection Agency’s website. The report has been made for the Danish EPA by DHI in cooperation with the Institute of Occupational Medicine, UK.

You are also welcome to address queries about the report to the joint author:

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


Children and exposure to chemical substances

Many chemical substances are regarded as potentially problematic for children’s health and development. In two current projects, we evaluate neurotoxic substances in children’s rooms and the overall exposure of children to selected chemical substances having neurotoxic and endocrine disruption properties. Both projects are funded by the Danish Environmental Protection Agency.

Neurotoxic substances in children’s rooms
Toluene is a neurotoxic solvent common in paint. Together with other potential neurotoxic substances that may be present in children’s rooms, we investigated if the substances could be problematic for children’s development of the nervous system. We evaluated emission from building materials, furniture, toys, electronics, etc. Based on the findings, we concluded that the levels of toluene and other neurotoxic substances in children’s rooms do not cause concern for adverse effects to the nervous system in children.

The study was carried out in cooperation with the Danish Building Research Institute. Read the report Survey and risk assessment of toluene and other neurotoxic substances in children’s rooms (pdf, 116 pages).

Exposure to endocrine disruptors and other substances
In a newly initiated project, we study the potential impact of exposure to neurotoxic substances and endocrine disruptors in small children and pregnant women/foetuses. The aim is to collect more knowledge and assess the potential risks of children/foetuses to the overall exposure to the substances. The assessment will be based on recent literature data and data from the many previous consumer surveys conducted by the Danish EPA. Also specific analytical chemical findings from selected consumer products such as food contact materials, finger paint and modelling wax will be included in the project. The study is carried out in cooperation with the Danish National Food Institute and FORCE Technology.

For more information the projects, please contact

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


Meet us

7th Biocides Symposium - Hungary
Senior consultant Michael Fink participates in the 7th Symposium focusing on authorisation of biocidal products and active substance approval under the European Biocidal Products Regulation. The symposium takes place on 10 - 11 May in Budapest.

Food Legislation 2016 – Denmark
Senior Toxicologist Helle Buchardt Boyd is invited to give a presentation on novel foods at the Danish Food Legislation 2016 conference, which takes place on 14 – 15 June in Copenhagen.

SEPAWA Seminar - Germany
Senior consultant Michael Fink is invited to give a talk at a seminar of the German branch of SEPAWA, the European association of detergents, cosmetics and fragrances. Michael will talk about the progress in approval of biocidal active substances. The seminar takes place on 30 June in Frankfurt am Main.


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