DHI Newsletter on Chemicals and Regulatory Toxicology

December 2017




Chemicals

Compliance check of substances in articles

Producers, distributors and importers of articles should be aware of their REACH obligations as articles may be inspected in an EU enforcement project launched in October 2017.

Several reports and actions indicate that industry does not comply with the REACH regulation on articles. The enforcement project wants to identify the reasons for this and at the same time to raise awareness and understanding of the legal obligations.

The project will focus on specific substances or groups of substances, including flame retardants, phthalates and perfluorinated substances. Articles are targeted because they are likely to contain Candidate List substances of very high concern (SVHCs) to which consumers may be exposed.

The project will run until the end of June 2018. See more here, including link to the Guidance on requirements for substances in articles.

For more information on substances in articles, please contact:

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


Sweden enforces registration of nanomaterials

The Swedish Chemicals Agency (KEMI) imposes a new requirement to notify data on nanomaterials in chemical products.

As of 1 January 2018, data on nanomaterials must be notified to KEMI’s product register. Companies have until the end of February 2019 to comply. The obligation applies to the manufacture and import of products. There is, however, an exemption for companies with annual sales of less than SEK 5m (€502,000).

For more information, please contact:

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


New Zealand reform on hazardous substances

Changes to the way hazardous substances are managed in New Zealand come into force on 1 December 2017.

The biggest change is that most of the hazardous substance rules, previously under the Hazardous Substances and New Organisms Act (HSNO), will from now on be set out in EPA Notices from the New Zealand Environmental Protection Authority.

By 1 December 2017, ten EPA Notices will be in force, including a classification notice, a labelling notice and a safety data sheet notice. An HSNO classification is comprised of a numbered class, subclass and lettered category.

New Zealand has additional hazard classes that are not part of GHS and vice versa.


Group standards are updated


Group standards for hazardous substances will be updated so that they refer to the EPA Notices. All group standards will be updated and published by 1 December.

Read more about the reform and see the EPA Notices here.

For more information on classification and labelling, please contact:

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

  • Visit our free GHS Portal to stay updated on GHS implementation worldwide

Danish legislation on antifouling paints

Antifouling products containing active substances, which are still in the review programme in accordance with the European Biocidal Products Regulation (BPR), fall under the Danish statutory order on antifouling products.

The Danish legislation has been updated with a few changes. It is still a requirement that antifouling products are registered and labelled. In addition, there is also some restrictions for certain types of sailboats in both freshwater and seawater.

Biocidal products already approved under the BPR will not be affected and can be placed on the market and used in accordance with their approval.

For more details, please contact:

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


Environment

Plant protection products -
new criteria for low-risk active substances

In August 2017, the EU Commission updated the criteria for approval of low-risk active substances. According to the new criteria, an active substance, other than a micro-organism, can not be considered as being of low-risk where it corresponds to any of the following:

  • carcinogenic category 1A, 1B or 2; or mutagenic category 1A, 1B or 2,
    toxic to reproduction category 1A, 1B or 2,
    skin sensitiser category 1, or causes serious damage to eye category 1,
    respiratory sensitiser category 1,
    acute toxicity category 1, 2 or 3; or specific Target Organ Toxicant, category 1 or 2, toxic to aquatic life of acute and chronic category 1 on the basis of appropriate standard tests, explosive, skin corrosive, category 1A, 1B or 1C;
  • it has been identified as priority substance under Directive 2000/60/EC;
  • it is deemed to be an endocrine disruptor;
  • it has neurotoxic or immunotoxic effects.

For further details, please refer to the Commission Regulation (EU) 2017/1432 amending the placing of plant protection products on the market as regards the criteria for the approval of low-risk active substances

In the annex to the above, it is clarified when an active substance, other than a micro-organism, should or should not be considered as being of low-risk. Furthermore, it is clarified when an active substance which is a micro-organism may be considered as being of low-risk.

As per August 2017, two chemicals and eight micro-organisms have been approved as low-risk substances.

For more information on plant protection substances, please contact:

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

Danish subsidies for environmental labelling

In Denmark, the Environmental Protection Agency wants to encourage the use of the Nordic ecolabel and the EU ecolabel for environmental product labelling. The EPA has previously subsidised consultancy services to Danish companies in ecolabelling. Currently, the EPA is extending the deadline for applications to the subsidy scheme to mid-December 2017.

DHI has assisted many clients in Scandinavia with environmental labelling, including the Nordic ecolabel, the EU ecolabel and the Swedish Byggvarubedömningen (BVB). We evaluate product compliance with regard to the labelling requirements. Furthermore, you may ask us to support you with your ecolabel application.

For more information, please contact:

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


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

Tool to compare global ecolabels

Worldwide, there are more than 465 ecolabels according to the global directory Ecolabel Index - and the number is increasing. DHI is engaged in development of a tool to compare the many ecolabels with regard to their requirements to human health and the environment.

The ecolabel tool is to carry out a thorough comparison of the many ecolabels and their requirements. The tool will focus on ecolabels for packaging and is targeted at producers, suppliers and users of packaging.

If you are interested in more information, or if you have suggestions for input for such a tool, please contact:

For more information on how aluminium affects human health, please consult:

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


Consumer Product

Limit value for aluminium in toys

The European Commission has published a tolerable daily intake of aluminium from toys of 0.3 mg/kg bodyweight/day. This value is recommended by the EU Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) in their opinion on migration limits for aluminium in toys.

The value has been calculated based on the assumption that 10% of the tolerable daily intake of aluminium should be allocated to migration of aluminium from toys.

Children are exposed to aluminium mainly via food, which is the largest source of intake. Exposure to aluminium from toys constitutes only a small part. Aluminium is a natural component in foods and in food additives. The substance is potentially harmful to health as it may accumulate in the body if you ingest more than the body can excrete. This is particularly critical for small children. Consequently, SCHEER recommends that children’s exposure to aluminium from toys should be minimised.

For more information on how aluminium affects human health, please consult:

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


CMR substances not allowed in toys

Toys and toy components must not contain substances classified as CMR in concentrations above the classification limits.

CMR substances are substances classified for carcinogenicity, mutagenicity or reproductive toxicity. In recent years, the classifications of a number of CMR substances have been updated with the CLP classification. If the classification of a CMR substance is updated, this may impact on the toys that contain the substance.


Example of revised classification


An example of this is formaldehyde. In 2015 the classification was tightened up from category Carc 2 to Carc 1B. As a result, toys may only contain 0.1% formaldehyde. The previous limit was 1%. Wooden toys, textile toy components and toy slime may contain formaldehyde.

Classification limits are the generic concentration limits, and they are determined in the CLP Regulation. The classification limits for CMR substances are as follows:


C (Carc) M (Muta) R (Repr)
1A 0.1 % 0.1 % 0.3 %
1B 0.1 % 0.1 % 0.3 %
2 1 % 1 % 3 %

In addition, there may be specific classification limits differing from the generic concentration limits. In such cases, the specific classification limits apply.

For more information on substance classifications and specific classification limits in Annex VI of the CLP Regulation, please visit our free GHS Portal. Furthermore, you should check your suppliers’ classification.

In addition to the above limits, other specific requirements apply to chemical substances in toys. Denmark, for instance, has a ban on phthalates above 0.05% in toys and articles for small children (age 0-3 years).

For information on substances in toys, please contact:

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


EU restriction proposal on hazardous substances in tattoo inks

Together with the competent authorities of Denmark, Italy, Norway and Germany, ECHA has prepared an EU restriction proposal to reduce the risks caused by hazardous substances contained in some tattoo inks.

The proposal is in line with legislation already in force in Belgium, France, Germany, the Netherlands, Slovenia, Spain, Sweden, Norway and Liechtenstein. A six-month public consultation will be launched in mid-December 2017.


Approx. 4,000 substances to be scrutinised


The aim of the proposal is not to ban tattoos but to regulate specific hazardous substances present in tattoo inks to ensure they are safe to use. Restrictions or concentration limits are expected to affect approx. 4,000 substances.

More information is available in the Restriction proposal on Substances used in tattoo inks and permanent make-up

The EU expert opinion on tattoo inks is expected by the end of 2018, and the draft decision by the European Commission in 2019.

For more information, you may also contact:

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


Food

Updated Danish regulation on food supplements

The Danish statutory order on food supplements has been revised as per November 2018. The revised amendments are as follows:

  • The maximum amount of vitamins and minerals in food supplements for adults and children from 11 years has been nullified. It is the responsibility of the company marketing a food supplement to ensure that the product is not harmful to health. The Danish National Food Institute has made new suggested maximum values for the content of vitamins and minerals.
  • Reference values for vitamins and minerals in food supplements for children (1-10 years) are obsolete and thus nullified. Companies should use the reference values for adults in the EU Regulation on the provision of food information to consumers (1169/2011) instead. The Danish National Food Institute has made new suggested maximum values for content of vitamins and minerals for children age 1-2 years and children age 3-10 years.
  • The minimum amount of vitamins and minerals in food supplements for adults and children (from 11 years) is nullified.
  • The requirement for labelling of food supplement for pregnant women and children under one year is nullified.

If you need safety assessments of food supplements or their single constituents, please contact:

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


Database of nutrient content in food

Frida Fooddata is a database created to facilitate public access to information about food substances. The database includes data on the nutrient content of various foods reflecting the food supply in Denmark. It is available on frida.fooddata.dk

Data can be searched by food name or found in alphabetical lists of foods, food groups and food components. In tables the nutrient content per 100 g edible portion of food is shown as average values. The database is created by the Danish National Food Institute, Technical University of Denmark (DTU).

The data from Frida Food Data is freely available when you state the source reference.

Similar databases can be found in other Scandinavian and European countries, and also in countries outside of Europe. However; not all databases are freely available.

For more information about food and nutrition, please contact:

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


Meet us at

Risk Assessment Joint International Symposium - Germany

From 30 November to 1 December, Helle Buchardt Boyd participates in the Joint International Symposium: Global Past, Present and Future Challenges in Risk Assessment – Strengthening Consumer Health Protection. The symposium is held in Berlin.

ChemCon - The Americas 2018

Helle Westphal and Henriette Christiansen will participate in the ChemCon Americas conference, which takes place in New Orleans, USA, on 5-9 February 2018.


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