Chemicals and Regulatory Toxicology Newsletter

April 2017




Chemicals

REACH enforcement project on safety and SDSs

Throughout 2017, the authorities of the 28 European Union and European Economic Area (EEA) member states will carry out inspections to check work place safety with regard to the use of hazardous chemicals. This is done to comply with the fifth REACH enforcement project REACH-EN-FORCE-5.

The national inspections will be carried out to ensure correct handling of hazardous chemicals, particularly substances of very high concern (SVHC), and to confirm that sufficient information is communicated all the way through the supply chain. This will include mapping of how effectively extended safety data sheets are communicated from manufacturers to the end users.

Proper information and communication
The inspectors will concentrate their efforts on extended safety data sheets to make certain that the information is consistent with the information in the chemical safety reports (CSR). Furthermore, exposure scenarios and observance of work place safety information will be scrutinised.

The inspections will be completed by the end of 2017 and a report will be available in the final quarter of 2018.

For questions concerning mandatory supplier documentation or safe handling of chemicals, please contact:

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


Know your lead registrant in SIEFs

With just about one year left before the REACH 2018 registration deadline, you should know who are the lead registrants of your substances to be registered by May 2018. As it appears elsewhere in this newsletter, it is the obligation of the lead registrant to submit the lead dossier and to keep the dossier updated - also after the 2018 deadline.

ECHA has published a list of substances for which the lead registrants have been declared. You can check the List of lead registrants here.

With the facilities in REACH-IT, it is possible for the lead registrant to announce himself as the lead registrant after acceptance of the role from the pre-SIEF members. If the lead registrant agrees, his name will appear on the list of substances with a lead registrant.

Information on the lead registrant will also be available in the Substance/pre-SIEF section of REACH-IT.
If no lead registrant has been declared, you may consider to act as the lead registrant yourself and perform the necessary actions.

REACH-IT is the official tool that must be used to submit, process and manage data and dossiers.

For more information, please contact:

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


Keep your REACH dossier updated after May 2018

The third REACH registration deadline of 31 May 2018 is a milestone for registration of phase-in substances on the market. It will, however, by no means put a stop to the REACH compliance work required by industry after May 2018.  The Lead Registrant must continue to maintain the dossier and must respond to requests from authorities and enquiries from other registrants that wish to join a registration.

It is a key requirement under REACH to keep the registration dossier updated. The continued work by authorities and the communication to downstream users are based on the hazard and safety assessment in the dossier. Updating of the lead dossier should be considered regularly, for instance once a year. The focus should be:

  • Identify new available hazard information on the substance: This may include new studies conducted as response to a requirement from ECHA. It may also include new available studies carried out under other registration schemes or published scientific research. The key requirement in REACH is that when new information becomes available, the registrant has to consider if this should be included in the dossier and if the hazard characterisation needs to be updated.
  • New use information: All registrations are based on the registrant’s knowledge at the time of the registration, including information on uses received through the supply chain. Additional uses may need to be included on request from existing or new registrants, or if new information on uses and use conditions becomes available. The Lead Registrant should consider updating the uses and assess if the use conditions are reflected in the exposure assessment.
  • New information requiring an update of the CSR: New information on hazard or use/exposure may trigger a need for updating the safety assessment in the Chemical Safety Report (CSR) and to communicate this to the downstream users via the SDS and exposure scenarios. 
  • Respond to requests for joining the registration: New registrants of the same substance have to register via a joint registration. Consequently, the Lead Registrant must include new registrants and offer a Letter of Access (LoA). The price of the LoA has to be based on a fair, transparent and non-discriminatory cost sharing model.

SIEF members and registrants joining the registration
The SIEF members and the joining registrants have their own Company Specific Dossier connected to the Lead Dossier. They have to rely on the Lead Registrant with regard to update of the dossier and should consider the following:

  • Ensure that the Lead Registrant maintains the dossier as required. The authorities will base their work on the dossier, such as compliance checks and inspections.
  • Make sure that all your uses are identified in the Lead Dossier or in your own CSR.
  • Communicate the latest updated hazard and exposure information to the downstream users via SDS and exposure scenarios.

For more information, please contact:

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


New procedure for notification of substances and materials in Denmark

The Danish Product Registry has closed the registry system, Probas. As of 1 April 2017, all notifications must be done via  www.onlineat.dk. From now on, all communication between the Product Registry and a company will take place online. When all information has been submitted, the notifier will receive a PR number (registration number).

Both Danish and foreign manufacturers can register chemical substances or materials. If you are a foreign manufacturer, you must be pre-approved to use the new platform. To do so, you must send an e-mail to pd@at.dk with information on the name of the user, name and address of the company and a mobile/cell phone number to which a code to the online platform will be forwarded.

Companies must give access to representatives
Companies that employ representatives or consultants to make notifications should be aware of one important change to previous procedures. In order for a representative to use the new notification system, the company must assign the representative the right to notify on their behalf. This is done on www.onlineat.dk. A company will get access to all information in a notification, including information in notifications made through a representative.

Raw material suppliers and confidentiality
To avoid that confidential information becomes available to his clients, at raw material supplier might be compelled to make the notification himself. Consequently, a raw material supplier that has no direct sale to Denmark must notify a raw material composition if the raw material is contained in products sold in Denmark.

The duty to notify substances and mixtures, including required information, is unchanged. For more information, visit the Product Registry’s webpage.

Queries on product notification can be addressed to:

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


Information on emergency health response to be EU-harmonised

The EU now implements requirements on submission of harmonised information on hazardous mixtures and preventive measures to national appointed bodies (Poison Centres). This is done by adopting Commission Regulation (EU) 2017/542 that amends the CLP regulation on classification, labelling and packaging of substances and mixtures.

Before placing on the market mixtures classified as hazardous based on their health or physical effects, importers and downstream users (submitters) shall submit the following information on the mixtures to the appointed national bodies:

  • Product identifier and UFI (se further information below)
  • Details on the company/person responsible for placing the mixture on the market
  • Telephone number and e-mail address for rapid access to additional product information
  • Classification and label elements
  • Toxicological information
  • Information on mixture components:
    • classified for health and physical hazards if above 0.1%
    • not classified ingredients if above 1%
    • components classified as Acute Tox. 1, 2 and 3; STOT SE 1 and 2; STOT RE 1 and 2; Skin Corr. 1, 1A, 1B and 1C; Eye Dam. 1 shall be listed with their exact concentration
    • concentration ranges can be indicated for all other components.

The amount of information may be reduced if mixtures are intended for industrial uses only (limited submission).

The information must be submitted in national language and using the XML format provided by ECHA at the site dedicated to Poison Centres.

Group submissions are allowed if the mixtures in the group have the same classification (health and physical hazards) and the same components with the same concentration ranges.

Mixtures that are classified only as gas under pressure and/or explosives (all divisions), are exempt from the requirement of the regulation.

Companies must comply with the new requirements from:

  • 1 January 2020: for mixtures for consumer use
  • 1 January 2021: for mixtures for professional use
  • 1 January 2024: for mixtures for industrial use only

Submitters that have already provided information on hazardous mixtures to national bodies before the above-mentioned deadlines must comply with the new requirement from 1 January 2025.

Unique formula identifier (UFI)
The UFI is a unique alphanumeric code that unambiguously links the submitted information on the composition of a mixture or a group of mixtures to a specific mixture or group of mixtures. The UFI shall be indicated in the submission form and affixed on the label of the mixture.

Submitters must generate the UFI using ECHA’s UFI generator that is free of charge. A new UFI is required if the composition of a mixture changes.

For more details on the new requirements, please contact:

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


Environment

Emerging zoonotic viruses

Following climate changes, new emerging zoonotic viruses might be on the way to Scandinavia. In the summer of 2016, Belgium, France, Germany and the Netherlands reported widespread Usutu virus (USUV) activity based on live and dead bird surveillance.

USUV is a flavivirus belonging to the Japanese encephalitis complex. Its hosts include primarily Culex mosquitoes, birds, and humans. The main vector Culex pipiens is already established in Denmark. Selected serum samples from migratory birds in the Danish West Nile virus programme were tested for USUV-specific antibodies, and one sample tested positive. No live virus was detected.

For more information, please read the article Widespread activity of multiple lineages of Usutu virus, western Europe, 2016 published on Eurosurveillance.org, or contact:

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


Food

Mineral oil may be more hazardous than presumed

Exposure to mineral oil from food contact materials, lip balms and lipsticks may be more hazardous than previously presumed.

In all probability, the accumulation of mineral oil saturated hydrocarbons (MOSH) in humans has been underestimated. This is the conclusion of a comparison of newly acquired rat data with previous data. The new data were generated by an international research group led by the Swiss Official Food Control Authority and they have been published in Science of the Total Environment.

May impact on ADI
The assessment of mineral oil fractions pose a specific challenge as they consist of a complex mix of substances. Based on the new study, it is proposed that it may be advisable to change the definition of the different fractions and to reevaluate the limit for acceptable daily intake (ADI). This may impact on the use of mineral oils in lip balms and lipsticks and also affect the assessment of recycled paper and cardboard as well as the use of printing ink in food contact materials.

For more information on exposure to substances, please contact:

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


Food allergen network

DHI participates in a newly established Danish network for manufacturers handling food allergens. The network will share knowledge on allergen control, analysis methods, limit values, risk assessments and regulation.

Controlling allergens all the way through the supply chain can be quite a task. Even minor amounts must be labelled, and performing risk assessments and analyses is resource demanding. DHI is particularly familiar with obtaining permission not to label allergens when it can be proven that no trace of allergen is present in a food or food ingredient, even though the original source may be allergenic ingredients.

The network is established in collaboration between DHI, the Danish Technological Institute and Food Diagnostics.

For more information on allergens, please consult:

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


NanoPack - antimicriobial food packaging

To enhance food safety and reduce waste, the European Union has awarded €7.7 million to the NanoPack project to introduce nanotechnology-based antimicriobial packaging. The aim is to develop antimicrobial packaging solutions for perishable foods and to demonstrate a solution for extending food shelf life by using novel antimicrobial surfaces.

DHI is one of eighteen international partners in the NanoPack consortium, which is coordinated by the Technion – Israel Institute of Technology. NanoPack is funded as part of HORIZON 2020, the EU Framework Programme for Research and Innovation.

We will lead the work package on human and environmental safety of nanotechnology and the safety of the final product.

Click to view the presentation of the project: Press Release

For more information, please contact:

Margrethe Winther-Nielsen
mwn@dhigroup.com
Tel +45 4516 9320


Life Science

Alternatives to animal testing

In vitro testing, QSAR models, grouping of chemicals and read-across are important alternatives when you want to assess the likely effects of chemicals without testing on animals. ECHA encourage the use of alternatives whenever possible, but although using alternatives is advisable it is also a complex discipline requiring expertise.

Suitable for low volume chemicals for REACH 2018

The deadline for registration of low volume chemicals under REACH is approaching. For these chemicals, human health and environmental data are often lacking and data on their identity, physical-chemical properties, uses and hazardous properties need to be provided.

For these registrations, alternative methods can be used instead of actual testing to draw conclusions for several information requirements. The alternative methods outlined in REACH are various: in vitro methods, quantitative structure-activity relationship (QSAR) models, and use of read-across or category approach - altogether used in an overall weight of evidence framework.  The level of information from these alternative methods should be equivalent to that produced by standard tests. ECHA has published specific guidance documents for registrants to fulfil data requirements.

Developing robust predictions requires expert knowledge
The use of alternatives to testing, and specifically the use of grouping of chemicals and read-across to fill in missing information, is a complex process and requires expertise in toxicology/ecotoxicology in a regulatory context. So far, ECHA has rejected the majority of registrations where read-across has been used. The reason for this is that the read-across justification and the scientific evidence to support the predictions have been inadequate. Consequently, using grouping of chemicals and read-across is highly recommended but should not be considered an easy solution to comply with specific data requirements.

Alternatives applicable for multiple purposes
At DHI, we use all of the above tools for chemical registrations under REACH and for worldwide registrations. In addition, the same approaches can be used in other areas such as cosmetic ingredients, pharmaceuticals, biocides and food contact materials. 

For more information on using alternatives to animal testing, please contact:

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

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


EU accepts four phthalates as endocrine disrupting substances

For the first time in the EU, four phthalates have been recognised as endocrine disrupting substances for humans, and it has been agreed to impose a restriction proposal on the phthalates in articles.

The four phthalates are DEHP, DBP, DIBP and BBP. They will now be included as endocrine disrupting substances for humans on the EU Candidate List of substances of very high concern (SVHC). The phthalates are already included on the Candidate List as toxic to reproduction. They are thus one step closer to being included on the REACH Authorisation List, requiring special authorisation from the EU to use the phthalates in articles.

Next step is ban on non-EU products
The Danish authorities have been the driving force behind the recognition of the phthalates as endocrine disrupting substances. Together with ECHA, Denmark will continue to push for a proposal to have the phthalates banned in products imported from non-EU countries.

For more information on the EU Candidate and Authorisation Lists, please contact:

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


Cosmetics

Ban on three perfume substances

A ban is expected to be passed in the EU on three allergenic perfume substances in cosmetic products. The ban will comprise:

  • Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC),
  • 2,6-Dihydroxy-4-methyl-benzaldehyde (atranol) and
  • 3-Chloro-2,6-Dihydroxy-4-methyl-benzaldehyde (chloroatranol)

HICC is used in the region of 1000 metric tonnes per annum and is present in both cosmetics and non-cosmetic products such as household cleaners and detergents. Atranol and chloroatranol are present in natural extracts such as oak moss and tree moss extract, which are widely used in fine perfumes, aftershave lotions and other cosmetic products. Oak moss absolute is, however, also known for its strong allergenic potential. The ban is proposed to reduce consumer exposure to the substances and to reduce the risk of fragrance contact allergy.

The proposal to ban the substances has been put forward based on opinions by the EU Scientific Committee on Consumer Products (SCCP) and the Scientific Committee on Consumer Safety (SCCS):

The proposed ban is expected to be under consideration by the EU for the next 3 to 5 months.

For more information on cosmetics and cosmetics regulation, please contact:

Lise M. Møller
lmm@dhigroup.com
Tel +45 4516 9133


Sweden to ban microplastics in cosmetics

KEMI, the Swedish Chemicals Agency, has already proposed a ban on microplastics in rinse off skincare products such as soap and shampoo. In 2017, KEMI will investigate if the ban can be extended to include more products.

Meanwhile, the Swedish government has proposed a bill that will make it possible to ban the use of microplastics in cosmetic product based on waste prevention with particular reference to health or the environment. Changes in the environmental legislation is planned to become effective on 1 August 2017.

For more information on risk assessment of cosmetic products, please contact:

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


Courses

For more information on courses and registration, please visit The Academy by DHI


Meet us at

Chemical Watch Expo 2017: REACH into the Future, Berlin, Germany
Meet Brian Svend Nielsen and Hülya Genc-Fuhrman when they participate in the Expo 2017 conference in Berlin on 25-26 April. They look forward to meeting you on stand 29.


Contact

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


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



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