News about Environment
and Toxicology

October 2014




Chemicals and biocides

GHS classifications and mandatory lists

In August 2014 the Korean GHS classification and labelling list was updated. The list is comprised of approximately 700 substances and includes hazard statements, signal words and pictograms. The classification of these substances has been mandatory since 2011.

Other countries have similar lists or inventories with substance GHS classifications. Some of these lists are mandatory to follow just as the Korean list.

If you are placing chemical products on various markets it is essential that you know when to apply the mandatory classifications. Furthermore, the classifications of the same substance might vary from country to country. Consequently, you can end up with different classifications for the same product. 

For more information on mandatory substance classifications for various countries, please contact

Henriette Christiansen
hc@dhi.com.sg
Tel +65 8611 5611


ChemClass – new classification tool

ChemClass is a new software tool developed by DHI, which calculates new hazard classifications for chemical mixtures based on the classification and concentration of the chemical substances in the mixture. It is possible to classify a mixture both according to the global GHS regulation and according to regional implementations such as the CLP regulation in the EU.

ChemClass is an add-on module to our chemical software ChemManager. ChemManager includes regulatory substance lists and modules for chemicals management as well as safety data sheet authoring. At present, ChemClass is available in a beta version. It will be available for purchase at the end of 2014.

For more information, please contact

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


List of biocidal active substance suppliers to include non-EU companies

Non-EU companies supplying biocidal active substances through an EU representative will be listed next to the representative in the upcoming list of biocidal active substances and suppliers (the Article 95 list). This has been agreed by ECHA and the European Commission. Likewise it will be possible for all non-EU manufacturers to appoint an EU representative.

From 1 September 2015, a biocidal product cannot be placed on the EU market if the substance supplier or product supplier is not included in the list for the product type to which the product belongs.

For more information on biocidal products and biocidal regulation, please contact

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


Benefit from pre-submission of biocides authorisation application

Companies intending to apply for an EU authorisation of a biocidal product are encouraged to make a pre-submission of their application. Pre-submission is not a legal requirement but a service offered by ECHA to check whether a biocidal product is eligible for authorisation.

There are several benefits to be obtained from a pre-submission:

  • verification of whether the product falls within the scope of the Biocidal Products Regulation
  • identification of the appropriate product type (depending on the use of the product it may not be regulated by the BPR regulation but by another legislation)
  • feedback if an EU Member State objects to the use of the product in their country

The pre-submission is to be initiated through a competent authority within the EU. Further, it must be submitted to ECHA via a pre-submission form and a draft summary of the product characteristics (SPC). Applicants can expect feedback from ECHA within 30 days.

For more information, please contact

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


Nine active biocidal substance opinions adopted

ECHA's Biocidal Products Committee has adopted a total of nine opinions on active substances. Thus, the nine substances are a step closer to final approval.

One substances of particular interest is propan-2-ol as it is used in various products. Propan-2-ol has been evaluated for use in three product-types: 

  • PT 1 (disinfectants for human hygiene)
  • PT 2 (disinfectants and algicides not intended for direct applications to humans or animals)
  • PT 4 (disinfectants for use in food and feedstuff)

For more details on the substances, see here.

For more information, please contact:

Estelle Giovalle
egi@dhigroup.com
Tel +45 4516 9205


Consumer safety

Public consultation on chromium VI in toys

Small children are a vulnerable subgroup and more exposed than other risk groups, for instance to oral exposure. One substance of concern as regards oral exposure is chromium VI, which has potential carcinogenic effects.

A source of chromium VI exposure for children is toys coated with copper chrome arsenate, such as treated timber toys. However, as children also ingest chromium VI from food and drinking water the exposure from toys should be to the lowest levels possible.

As a result, the European Commission and its non-food Scientific Committee on Health and Environmental Risks have launched a public consultation on a preliminary opinion on chromium VI in toys. The purpose of the opinion is to consider whether the migration limits for chromium VI in toys must be revised. Read more on Public Consultation on the preliminary opinion on chromium VI in toys.

For more information on toys and chemical exposure, please contact

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


In vitro skin sensitisation tests on cosmetics

A validated alternative to the golden standard test for skin sensitisation, the local lymph node assay (LLNA) test, is now available. It is provided by the international CRO CiToxLAB in a new and comprehensive package of in vitro skin sensitisation tests.  Skin sensitisation is a contact allergic reaction (dermatitis) associated with chemicals or cosmetics exposed to the skin.

The in vitro skin sensitisation test is a complicated step-wise process requiring a tiered approach to safety assessment:

  • Step 1: DPRA- Direct Peptide Reactivity Assay absorption and haptenation (binding) of the chemical with cellular proteins. 
  • Step 2: KeratinoSens™ - Luciferase ARE reporter assay in a keratinocyte cell line. Initiation of a dermal inflammatory response and activation of the Nrf2 pathway.
  • Step 3: MUSST- Myleloid U937 Skin Sensitisation Test. Determination of CD86 activation in U937 cells by flow cytometry. Dendritic cell activation.

If you need assistance with testing of cosmetic ingredients or products for regulatory purposes, please contact

Ann Detmer
ad@dhigroup.com


Substitution of endocrine disrupting phthalates in EU well on the way

A survey carried out by the Swedish Chemicals Agency reveals that four endocrine disrupting phthalates to a great extent are being substituted by less hazardous alternatives in products manufactured in the EU. The four endocrine disrupting phthalates comprise DEHP, DBP, BBP and DIBP. In goods manufactured outside the EU, DEHP is still the most commonly used phthalate.

As of 21 February 2015 and in compliance with the REACH regulation, the four phthalates must not be used in the EU unless the use has been authorised by the EU Commission. However, this authorisation does not include products imported from non-EU countries.

In February 2015, ECHA will investigate whether it is possible to impose an EU restriction on goods containing any of the four phthalates.

For more information on substitution of phthalates, please contact

Ann Detmer
ad@dhigroup.com


Food

Industry hesitates to supply data on food ingredients

The European Food Safety Authority, EFSA, regularly issues calls for information on food ingredients. Presently, EFSA is re-evaluating the use and health impacts of food ingredients but has received surprisingly little information on additives and enzymes.

At the CIR Conference in Barcelona in September, EFSA emphasised that if they do not receive sufficient data to evaluate a substance they will either conclude that

  1. data for evaluation is inadequate
  2. the substance should be withdrawn from the positive list or
  3. the permitted concentration in food should be lowered

It will then be up to the European Commission to decide the future of the substance.

The lack of data may be because it is difficult to estimate consumer intake of an additive or the fact that EFSA's recommended model (the budget model) exaggerates intake. In addition, it may be difficult to get hold of specific substance studies.

Additive and enzyme evaluation process ongoing until 2018
At present, EFSA is re-evaluating food ingredients and technological enzymes for use in food production. Additives are evaluated in phases and a number of food colourings, preservatives and antioxidants must be evaluated by the end of 2015 and 2016, respectively. The remaining substances must be evaluated by 2018. For enzymes a registration dossier must be submitted by March 2015 if they are to be entered on the EU positive list.

We are very experienced in estimating consumer intake of food and food ingredients as well as procuring data for evaluation of different substances.

For more information, please contact

Eva Høy Engelund
ehe@dhigroup.com
Tel +45 4516 9096


Authorised EU list of food enzymes

As mentioned above, EFSA is presently assessing food enzymes. The purpose is to establish a future authorised EU list of food enzymes. EFSA expects to carry out safety assessments of around 300 food enzyme applications in order to establish the authorised list.

The list will cover enzymes with a technological function in the manufacture, processing, preparation, treatment, packaging, transport and storage of food. Further, it will include food enzymes used as processing aids. However, it will not include food enzymes intended for human consumption such as nutritional purposes.

The deadline for submitting food enzyme applications is 11 March 2015.

Until the authorised list becomes reality, the current national rules on the use and marketing of food enzymes will apply.

For more information on food enzymes, please contact

Eva Høy Engelund
ehe@dhigroup.com
Tel +45 4516 9096


Wine and spirits with phthalates

A French study from 2014 of phthalate contamination of 100 wines and 30 spirits revealed that 59% of the wine samples contained significant quantities of dibutyl phthalate (DBP). Furthermore, aged grape spirits analysed were often excessively contaminated with another phthalate, DiBP.

Due to their low solubility in water, phthalates migrate more easily into products with high ethanol content. As a result, spirits are likely to contain higher phthalate concentrations than wines.

The source of contamination
The major source of contamination is the epoxy coatings used in vats used to store wines and spirits. Plastic corks and wine bags for final sale were shown not to be a problem. Phthalates were also identified in the walls of polyester-and-glass-fibre vats and in some epoxy resins.

Read the full study of Contamination of wines and spirits by phthalates: types of contaminants present, contamination sources and means of prevention online in Food Additives & Contaminants.

For more information on food contamination, please contact

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


Meet us

SCIC-Logistics & Distribution Conference, Singapore
Ms Henriette Christiansen has been invited to give a talk on Globally Harmonised System (GHS) Updates and Regulatory Updates for Asia Pacific at The Singapore Chemical Industry Council (SCIC) Logistics & Distribution Conference 2014 in Singapore on 15 October.

Courses – autumn 2014

IUCLID 5: Training for REACH and Biocide Registration Dossiers – 19 + 20 November, Denmark

For Danish courses in Environment and Toxicology, please see here.

Contact

DHI | Agern Allé 5 | 2970 Hørsholm | Denmark
Tel: +45 4516 9200 | Fax: +45 4516 9292 | www.tox.dhigroup.com



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