Newsletter on Chemicals and Regulatory Toxicology

November 2018


Chemicals

Mexico's GHS standard now fully in force

In 2015 the Ministry of Labor and Social Welfare published the standard NOM-018-STPS-2015 on hazard communication, labelling and Safety Data Sheets requirements for chemical products. With the standard, Mexico adopted the fifth revision of GHS.

The standard allowed the industry a three-year transition period that has now come to an end. As of 9 October 2018, the standard is mandatory. The standard covers hazardous chemicals in the workplace. Environmental hazards and a few other hazard categories are not regulated under the standard.

You can find link to the standard and other information on implementation at our free GHS Portal

For further information on GHS and safety data sheets for Mexico, please contact:

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


New adaptation to CLP regulation

The preservative MIT has been included in the list of harmonised classification and labelling after the European Commission has published its latest adaptation to technical progress to the CLP Regulation on the classification, labelling and packaging of substances and mixtures.

The new adaptation includes an amendment to the list of harmonised classification and labelling of hazardous substances, Annex VI. The amendment comprises 34 substances. For some substances the classification and labelling have been amended, other substances are new on Annex VI.

The substance methylisothiazolinone (commonly known as MIT) has been included in Annex VI with a harmonised classification as skin sensitising in category 1A. The lower classification limit is 0.0015%. This means that a product containing even very small amounts of the substance may be classified as skin sensitising. MIT is a common preservative in personal care products and paint.

The new classifications apply from 1 May 2020, but may be used for classification and labelling already now.

For more information on classification and labelling, please contact:

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


EU restricts 33 substances in clothing and textiles

With a new amendment of the EU REACH regulation in the pipeline, 33 substances will become restricted for use in clothing, footwear and textiles.

The 33 substances are classified as carcinogenic, mutagenic or toxic for reproduction (CMR substances). The new rules set maximum concentration limits for the use of CMR substances in clothing and textiles. This will prohibit products from being placed on the EU market if the products exceed these limits, regardless of their origin of production. The rules will become applicable 24 months after publication of the regulation.

The new amendment, including an annex listing the 33 substances, are available in official EU languages her.

For more information, please contact:

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


Brexit: where to find advice and information on chemicals

Although negotiations on the UK withdrawal from the EU currently are almost at a standstill, negotiations are still aiming for a Withdrawal Agreement. Provided that an agreement is reached, the EU-UK trade will be able to continue during an implementation period on the same terms as now up until the end of 2020.

You should pay particular attention if you are an EU-based company purchasing substances directly from a UK manufacturer. Depending on the outcome of the Withdrawal Agreement, you may need to register the substances yourself as an importer.

Regardless of the outcome, we advise you to stay updated on how chemicals regulation will be affected and to check the following websites regularly:

  • ECHA’s web section on the UK’s withdrawal from the EU, including general advice related to the fact that UK companies from 30 March 2019 will be non-EU companies and a Q&A section. The Q&A section covers both REACH, CLP and the BPR regulations.
  • The UK Health and Safety Executive’s (HSE) information page about what businesses need to know about chemicals during the implementation period. HSE enforces chemicals regulation in the UK.

For more information, please contact:

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


Easier to check REACH dossier evaluation process

The European Chemicals Agency, ECHA, encourages companies to be proactive and check whether there are activities under REACH and CLP for substance that they produce or use. For this purpose you find the public activities coordination tool (PACT) at ECHA’s web portal.

In a separate table linked to the PACT you can now identify and follow substances that are under evaluation and also track the progress of the evaluations. The list currently contains almost 2,700 substances. See ECHA’s Dossier Evaluation status.

For more information on substance evaluation, please contact:

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


Diesel fumes added to list of harmful substances in workplaces

The European Parliament has adopted a proposal from the Commission to set exposure limit values for additional cancer-causing substances and thus amend the EU-directive on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (2004/37/EEC).

It is new that diesel engine exhaust emissions is added to the list. This will affect some 12 million workers in the EU potentially exposed to diesel engine exhaust. Furthermore, exposure limit values are included for exposure to five additional carcinogenic substances: trichloroethylene, 4,4-methylenedianiline, epichlorohydrine, ethylene dibromide and ethylene dichloride.

It is expected that the amendments will be adopted in early December. The transposition period will be two years.

See press release from the European Parliament here.

For more information, please contact:

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


Biocides

Active chlorine dossier split into two

In April 2018, ECHA’s Biocidal Products Committee (BPC) published its opinion on the approval of the biocidal active substance “Active chlorine generated from sodium chloride by electrolysis” for product-types 1-5. During the evaluation of the biocidal active substance, however, it was decided that the active substance dossier in fact covered two distinct active substances.

As a result, the active substance named “Active chlorine released from hypochlorous acid” was split off from the original dossier. This substance now has its own official entry in the biocides active substance list. The newly named active substance covers the bottled use of in-situ formed active chlorine, whereas the “old” active substance covers the in-situ formed active chlorine that is being generated and used at site.

This split is rather unusual and has direct implications on the Article 95 list and on future product authorisations.

For more information about biocide substances and dossiers, please contact:

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


Review of three active substances for endocrine properties

The EU competent authorities (CAs) for biocides have decided that three approved biocidal active substances must be reviewed for endocrine disrupting properties.

The three substances are:

  • iodine for use in product-types 3, 4, 8 and 22
  • polyvinyl-pyrrolidone iodine for use in product-types 3, 4, 8 and 22
  • zineb for use in product-type 21

The substances have been selected based on a previous screening study where the substances were identified as possible endocrine disruptors. Read more in Draft note for agreement by member states' competent authorities for biocidal products (section 4 and annex).

For more information about biocides and endocrine disruptors, please contact:

Thit Aarøe Mørck
tam@dhigroup.com
Tel +45 4516 9567


Mandatory regulation puts pressure on disinfection industry

With the ongoing implementation of the EU Biocidal Products Regulation (BPR), industries dealing with biocides in their products are feeling the regulatory changes for real. One industry feeling the regulatory pressure right now is the disinfection industry covering healthcare, food and feed, veterinary hygiene and private hygiene.

Read more in our blog on No authorisation – no market: Mandatory biocidal regulation puts pressure on industry.


Transport of dangerous goods

Amendments to regulations for transport by road and rail

New amended editions of the European regulations governing the transport of dangerous goods by road and rail will become effective as per 1 January 2019.

Transport by road is regulated by ADR, the European Agreement concerning the International Carriage of Dangerous Goods by Road; transport by rail is regulated by RID, the Regulations concerning the International Carriage of Dangerous Goods by Rail.

Some of the significant changes in the updated ADR and RID include:

  • The term “risk” is changed to “hazard” throughout ADR and RID.
  • The classification for corrosive substances (section 2.2.8) is rewritten in accordance with GHS.
  • Ammonium nitrate based fertilizer (UN 2071) and Dangerous goods in machinery or in apparatus (UN 3363) will be included in the ADR on certain conditions.
  • Provisions for transport and packaging of lithium cells and lithium batteries collected from private households for further processing.
  • Chapter 7.1 will be named “General provisions and special provisions for temperature control”. Furthermore, a new section is added for transport of self-reactive substances, organic peroxides and substances stabilized by temperature control.
  • Concerning loading and unloading it is specified that this covers the vehicle crew and not just the driver.

Compliance with the above is optional from 1 January 2019 and mandatory as of 1 July 2019.

Transitional periods discontinued
With implementation of the new ADR and RID, some of the previous transitional periods will not apply as of 1 January 2019. This includes:

  • Labelling of packaging for lithium cells and lithium batteries. From 1 January 2019 the warning label on the packaging must comply with model 9A.
  • Fixed and detachable tanks with the code L1.5BN intended for transport of substances in class 3 must not be used for this purpose after 1 January 2019.

For more information on the ADR and RID, please contact

Ingelise Dige Semark
ids@dhigroup.com
Tel +45 4516 9221


Amendments to air and maritime transport

The new International Maritime Dangerous Goods Code, IMDG 39-18, has been published and is available for purchase, for instance through IMO, the International Maritime Organization. Many of the new amendments for transport by road and rail also apply to IMDG. This includes change of the term “risk” to “hazard” throughout IMDG and the classification for corrosive substances.

Some amendments, however, only apply to the special conditions for maritime transport. Please refer to Overview of the changes to the IMDG Code in the Amendment 39-18 update. for more details.

The 60th edition of the regulation on The International Air Transport Association’s (IATA) Dangerous Goods Regulations (GDR) will become effective on 1 January 2019. It also includes several of the amendments that apply to the regulations for road, rail and maritime transport. For a full overview, please read Significant changes and amendments to the 60th edition (2019)

For more information, please contact:

Ingelise Dige Semark
ids@dhigroup.com
Tel +45 4516 9221


Food

Polyamide oligomers migrate from kitchenware to food

Polyamide utensils are widely used as kitchenware, but certain components from the polyamide (PA) can migrate from the kitchenware into food.

The German Federal Institute for Risk Assessment (BfR) has reached this conclusion after assessing the health risks of ring-shaped oligomers migrating from certain polyamide types. PA oligomers are compounds made of a small number of molecules that may occur non-intentionally during hardening (polymerisation) of the plastic. Due to their low molecular size, they can diffuse through the plastic and migrate into food.

When applying the threshold of toxicological concern (TTC) concept, a daily intake of up to 90 micrograms of the individual ring-shaped PA oligomers is not likely to pose a health risk. However, studies conducted show that ring-shaped PA oligomers are likely to migrate at higher levels from kitchenware into food.

A full version of the BfR opinion is available in German: Polyamid-Oligomere: Kunststoffbestandteile aus Küchenutensilien

For more information on substance migration, please consult:

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


Novel foods – hard to reach an agreement on botanicals

During recent years, there has been a rapidly growing interest in using botanicals in the food industry and among restaurant chefs. Surprisingly, many such plants contain toxic compounds, which may be problematic for health if consumption increases. Due to limited historical data on food use from ethnobotanical surveys, the use of certain plant parts may be considered novel and as a result require approval for marketing.

Italy makes a stand on botanicals
In 2017, Belgium in collaboration with France and Italy published a decree authorising more than 1,000 botanicals in food supplements. This decree is known as the Belfrit list. Just 18 months later, Italy allows a new and more liberal use of plants with an updated decree that is not aligned with the Belfrit list.

Read more in this news from NUTRAingredients.com

Denmark requests better information on novel food status
In Denmark, a research group has conducted a review of wild and cultivated flowers served in restaurants. As part of a control campaign, the Veterinary and Food Administration visited 150 restaurants and local food producers in 2016 and investigated their use of plants picked from the wild, cultivated in private gardens or market gardens.

Among the species used were the flowers from 23 plants. Many of these flowers may be considered novel. Several flowers contained compounds with toxic or potentially toxic effects if eaten, unidentified toxic compound(s), or potentially toxic compounds present in other plant parts. Although the review is not exhaustive, the conclusion is that there is a general lack of chemical and toxicological data of many of the flowers used as food.

For more information on novel foods, please contact:

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


Webinar

Webinar: Calculation of migration of chemical substances from food packaging

Join our free webinar on chemical substances in packaging materials and learn about tools to avoid problematic substances. At the webinar we present experience gained through the project "Environment and Health in the Design and Supply Chain". The purpose of the project is to provide tools for designing recyclable packaging material and avoiding problematic substances.

Tools will be demonstrated via three case stories:

  • Selection of packaging materials that comes into contact with food. Which hazardous substances can be present in the packaging material?
  • A hazardous substance has been measured in a recycled PET packaging material used for food. Will it be a health problem?
  • To calculate migration, data is required for the packaging material itself, the migrant and food for which the packaging is used. In addition, data on the interaction between food, migrant and packaging material is required. How can you find these data - and can you calculate the data?

When: Wednesday, 12 December 2018, 2-3 pm (Copenhagen time zone = UTC -1 hour)

Instructor: Dorte Rasmussen, Senior consultant

Sign up: Participation is free. If you want to join the webinar, please send an e-mail to Vibeke Salmon: ves@dhigroup.com



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