News about Environment and Toxicology

Apr 2014


Chemicals

BPR amendments adopted by EU

A number of important amendments to the Biocidal Products Regulation (BPR) were adopted in February 2014 by the European Parliament. Some of the amendments include:

Biocidal product families
The amendments allow for biocidal products with less severe classifications to be part of a biocidal product family of higher risk formulations provided that the products have similar composition, exposure levels, and proven efficacy.

Extension of the list of approved suppliers and mandatory data sharing
In addition to manufacturers and importers of an active substance, the amendment includes the option under Article 95 for formulators using an active substance (“product suppliers”) to apply for inclusion on the list of approved suppliers themselves. Furthermore, mandatory data sharing has been extended to data on environmental fate and behaviour (in addition to toxicological and ecotoxicological data) and include non-vertebrate studies.

Renewal of the approval of an active substance
Authorised suppliers can only remain on the Article 95 list if they submit the relevant data or a letter of access to the data within 12 months from the renewal.

For more information on biocidal products, please contact

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

How to compose a Letter of Access

When you register a plant protection product or a biocidal product in Sweden and you are not the proprietor of all the supporting studies, you will need a Letter of Access (LoA). The LoA is required for those studies you do not own yourself. The LoA documents that you have permission to use the studies in your application. Furthermore, the LoA must be written in a specific way.

The Swedish Chemicals Agency (KEMI) has issued a new guidance on the use of the LoA. You can view all required features here.

If you do not comply with the requirements, obviously this will delay the handling of your application. If you need assistance with preparation of your Swedish product application, please feel free to contact DHI.

Ann Detmer
ad@dhigroup.com

Highlights of chemicals regulation worldwide

More than 300 participants from industry, authorities and organisations met in Istanbul in early April to learn about and benchmark their knowledge on Global Regulatory Compliance at the ChemCon Europe 2014 Conference.

Different approaches to REACH-like regulation
The general impression from the conference was that REACH has been successfully applied in the EU. Further that the REACH legislation has inspired several other countries to develop a REACH-like legislation such as K-REACH for South Korea, China REACH and Turkey REACH.

The chemical regulations in China, Indonesia, Thailand, Taiwan, Australia, New Zealand and North America differ from REACH, however, and have very different approaches to registration.

Some of the topical news at the conference included:

  • In the EU a survey has been was carried out by the national authorities, and an inspection of the Safety Data Sheets showed that 52% of the SDSs are non-compliant with the current EU regulation.
  • The REACH registration dossier is not a one-off event. ECHA expects the registrants to update their registration dossiers. When seeking an authorisation, the data in the dossier must reflect and support the application.
  • Turkey is adapting to EU chemicals regulation but has decided not to implement IUCLID but a IUCLID-like online tool for substance registrations in Turkey.
  • When registering a substance according to the requirements in China, only test results from tests run in China with Chinese organisms will be accepted as part of the registration dossier.
  • OECD definition on polymers is now widely accepted in most regions.

Public awareness of chemicals
A growing public awareness and demand for information on chemical risks require industry to respond to these requests. Regulatory authorities are working towards protecting human and environmental health but at the same time taking into account the industry’s commercial concerns.

ChemCon Europe 2014 is a global platform and brought together experts from over 25 countries. DHI representatives from our offices in Denmark, Turkey and Singapore attended the conference.

For more information, please contact

Hülya Genc-Fuhrman
hgf@dhigroup.com
Tel +45 4516 9256

Henriette Christiansen
hc@dhigroup.com

Singapore adopts 4th revision of GHS

On 7 March 2014, Singapore Chemicals Standards Committee launched the updated version of Standard SS 586:2014. Part 2 of the standard covers GHS classification and labelling and is now aligned with the 4th revision of the UN GHS. The standard has taken immediate effect.

Important changes
Major changes are clearer definitions of container labelling including reduced labelling, workplace labelling, and training. The updated SS 586:2014 adopts classification of substances and mixtures hazardous to the ozone layer, gases and aerosols as well as skin and respiratory sensitisation.

For more information on the standard and implementation in Singapore, please contact

Henriette Christiansen
hc@dhigroup.com

CLP in Turkey

Turkey has implemented CLP in December 2013. The responsible authority for implementation of the Classification, Labelling and Packaging Regulation (SEA Regulation) is the Ministry of Environment and Urbanisation.

The SEA Regulation implements the 3rd revision of GHS corresponding to the 2nd ATP (adaptation) to CLP. Highlights are listed below.

  1. The following building blocks are not implemented:
    • Chemically unstable gases, all categories
    • Non-flammable aerosols (Aerosol, category 3)
    • Flammable liquids, category 4
    • Acute toxicity, category 5
    • Skin Corrosion/Irritation, category 3
    • Aspiration hazard, category 2
    • Aquatic Acute toxicity, category 2 and 3
  2. The provisions of the Regulation will be mandatory from 1 June 2015 for substances, and from 1 June 2016 for mixtures, except for substances and mixtures placed on the market before 01/06/2015 and 01/06/2016 respectively, for which the deadlines are 01/06/2017 and 01/06/2018 respectively.
  3. In the transition period 01/06/2015 to 31/05/2016, substances shall be classified according to both the old regulation (SAE) and the new SEA Regulation but labelled only according to the new regulation.
  4. Classification according to the new system for substances placed on the market before 01/06/2015 shall be notified to the competent authority in the period 01/06/2014 to 01/06/2015.

Stay updated on GHS implementation in Turkey and worldwide on http://ghs.dhigroup.com/

For more information on the GHS and CLP Regulations, please contact

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

New EU restriction on Chromium VI

On 26 March 2014 a new restriction on Chromium VI was published in the European Official Journal. The restriction concerns leather articles coming into contact with the skin. Please note in particular that:

(leather articles) shall not be placed on the market where they contain chromium VI in concentrations equal to or greater than 3 mg/kg (0,0003 % by weight) of the total dry weight of the leather.

The restriction does not apply to second-hand leather articles placed on the EU market before 1 May 2015.
The restriction applies from 1 May 2015.

The restriction has been adopted through the Commission Regulation (EU) No 301/2014, amending Annex XVII to REACH.

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

Consumer app on Candidate List substances

A new Danish app is making it much easier for consumers to request information on SVHC substances, i.e. substances on the REACH Candidate List.

According to the REACH regulation, companies that market articles containing Candidate List substances in a concentration above 0.1 % weight by weight in the individual parts have an obligation to inform a consumer about the content if asked. It is specified that the consumer must receive an answer within 45 days.

The aim of this new app is to put pressure on the industry to contemplate the possibility of substituting the 151 substances presently on the Candidate List.

Joint European consumer database
The app is launched jointly by the Danish EPA and the Danish Consumer Council and is inspired by a similar German initiative. The goal is to establish a European database that can be used by all the countries that want to join the system.

For more information about the app, read here.

For questions regarding consumer products and chemicals, please contact

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

Life science

Alternatives to phthalates in medical devices

Industry associations support the phase-out of the use of classified phthalates in medical devices; legislation on phthalates is, albeit slowly, making progress, and experience from industry proves that substituion is possible. This was the overall conclusions of the international conference Alternatives to Classified Phthalates in PVC Medical Devices held in Copenhagen on 27 March.

Report on alternatives to phthalates
The conference was centrered around a report by DHI on alternatives to classified phthalates in medical devices. In this report ten commercially available alternatives have been examined for human and environmental effects. Attention has been on alternatives to the phthalates DEHP, BBP, DBP and DIBP, in particular alternatives to DEHP.

The report concludes that alternative plasticisers to DEHP are available. However, for some of the alternatives more data in terms of human health and environmental evaluation are needed. Moreover, technical aspects impact on whether and to what extent classified phthalates in medical devices can actually be replaced and the products still have the necessary properties for disease treatment.

Substitution is possible
The medical device manufacturer AMBU has been successful in substituting phthalates. At the conference they presented a phthalate-free laryngeal mask and reported the technical and economic challenges they have had to surmount before they were ready to market the mask. The technical challenges included formulation, processing and the final technical properties of the product.

Legislative phase-out
An impending legislative phasing out of phthalates in medical devices cannot be expected but will take time. However, tripartite discussions between the European Parliament, the European Council and the European Commission are on-going in terms of a future ban on classified phthalates.

View the DHI report on Alternatives to classified phthalates in medical devices. The report has been commissioned by the Danish EPA and the Danish Health and Medicines Authority.

For more information on the report or on phthalates, please contact

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

Dorthe Nørgaard Andersen
dna@dhigroup.com
Tel +45 4516 9088

Environment

Highly fluoridated compounds contaminate water sources

In Sweden, several findings have been made of high levels of highly fluoridated compounds like perfluoridated alkylic acids (PFAA) in waterworks. The findings have led to the closure of the affected water sources. Similarly, a finding has been made in Denmark in close vicinity to an airport.

From the mid-1980s until around 2003, these highly fluoridated compounds were used in fire-fighting foam. The compounds are very persistent and can dwell in nature for extended periods of time and seep into the groundwater.

Guidance value
If your water well is in the vicinity of a current or former firefighting training area, you are advised to analyse your water for existence of highly fluoridated compounds. Sweden and Denmark do not yet have any specific maximum concentration values for PFAAs in drinking water. In Germany, a limit of maximum of 100 ng/L of the sum of the perfluoridated compounds PFOS/PFOA is set and can be used as a guidance value.

If you want to know more, please contact

Ann Detmer
ad@dhigroup.com

Food

Call for data on food additives

As part of the ongoing re-evaluation of food additives, EFSA is now calling for data for the third batch of additives.

These additives include silver, gold, erythorbic acid and sodium erythorbate, lecithins, TBHQ and a host of gelling agents and thickeners. EFSA requires information on the additives’ usage level and/or concentration data in food and beverages intended for human consumption. To view the entire list of substances, click here.

Data must be submitted before 31 July 2014 to be sure that they are taken into account.

DHI is experienced in this kind of data retrieval and data submission and would be happy to assist you.

For more information, please contact

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

War against Listeria

Despite great societal efforts to combat Listeria monocytogenes contamination in ready-to-eat foods, the number of diseased people is not diminishing. This is an equal trend both in Europe as a total and in the Nordic countries. A recent Swedish outbreak of the critical bacterial infection Listeriosis partially closed a large meat production unit for extra cleaning and testing

To help combat Listeriosis, EFSA has published a fact sheet about Listeria. The fact sheet is also available in German, French and Italian, click here.

If you need a helping hand with preventive measures against Listeria contamination in your facility, DHI can assist you. We can be the independent party catching weak spots in the production facility before it fails.

For more information, please contact

Ann Detmer
ad@dhigroup.com

Reevaluation of aspartame finished

The current Acceptable Daily Intake (ADI) of the artificial sweetener aspartame stands. This is the conclusion following a reevaluation of aspartame (E 951) by EFSA’s Panel on Food Additives and Nutrient Sources added to Food (ANS). The reevaluation included mode of action and weight of evidence as well as new studies. Consequently, the current ADI of 40 mg/kg bw/day remains unchanged.

Aspartame is rapidly and completely hydrolysed in the gastrointestinal tract to phenylalanine, aspartic acid and methanol. At the current ADI the risk of phenylalanine toxicity of the unborn foetus from the mother’s intake of aspartame is negligible. Methanol is degraded via formaldehyde but based on recent measurements of basal levels of formaldehyde in blood, and on the modelling of its biological turnover and steady concentration state in cells, formaldehyde formed from aspartame-derived methanol was not a safety concern at the current exposure estimates or at the ADI of 40 mg/kg bw/day.

No evidence of neurotoxicity
In addition, the ANS Panel concluded that concerning the metabolite aspartic acid there is no evidence in vivo of neurotoxicity associated with aspartame exposure. For the degradation product DKP (5-benzyl-3,6-dioxo-2-piperazine acetic acid) present as an impurity, the Panel concluded that the exposure is below the ADI for DKP when used at the current ADI of aspartame.

For more in-depth information, please read the Scientific Opinion on the re-evaluation of aspartame (E 951) as a food additive (pdf, 263 pages).

For questions concerning food additives, please consult

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

Zero tolerance to chloramphenicol questioned

Chloramphenicol (CAP) is a broad-spectrum antibiotic. In the EU the use of CAP is prohibited in food producing animals because of its rare but potentially lethal hazard to human health. However, CAP is naturally occurring in soil, produced by the bacteria Streptomyces venezuelae, and can thus be absorbed by crops such as grain and maize and hereby transferred to silage and animal feed.

CAP found in pork meat
The Dutch research institute RIKILT has detected very low levels of CAP in meat and feeding stuff. Furthermore, the Swedish discovery of CAP in pork meat in late 2012 was most likely caused by CAP occurring naturally in straw and has called in question the present zero tolerance for CAP.

It would seem more reasonable to introduce a limit value for occurrence of CAP in meat and meat products. For the time being it would be advisable to add CAP to the list of potential hazards to meat production, and primary producers should analyse for CAP in their own check programmes.

For more comprehensive details, please refer to chapter 4 of the thesis LC-MS residue analysis of antibiotics, What selectivity is adequate? by Bjorn J.A. Berendsen et al. (2013).

For more information on risk assessment of CAP, please contact

Torben Wilde Schou
tws@dhigroup.com
Tel +45 4516 9504

Jackdaws died from caffeine

Sudden and unexplainable deaths among crowds of jackdaws seem to have been solved. The cause of death is believed to be caffeine intoxication. Analyses carried out in the USA showed that the internal organs of all the dead birds contained caffeine. A normal cup of coffee holds enough caffeine to kill four grown jackdaws.

Consequently, coffee grounds should not be thrown outside where birds or animals can get access to it.

For more information on risk assessment of CAP, please contact

Contact:

Ann Detmer
ad@dhigroup.com


Meet us

European Committee for Standardization, Bruxelles
Estelle Bjørnestad is appointed national expert by the Danish EPA and Danish Standard for a workshop on Ecotoxicity and Construction Products under the European Committee for Standardization’s Technical Committee CEN/TC 351 on 9 April 2014, Bruxelles.

GHS Conference, Singapore
Henriette Christensen has been invited to give a talk on the GHS implementation status globally at the Conference on the Globally Harmonised System (GHS) of Classification and Labelling of Chemicals 2014 in Singapore on 6 May. The day before the conference Ms Christensen hosts an all-day workshop on GHS.

SEPAWA Nordic, Sweden
Michael Fink has been invited to give a presentation entitled Status of the new Biocidal Products Regulation and its impact on formulators at the SEPAWA Nordic conference in Sweden on 5 - 6 May. SEPAWA is an association of industry partners within the field of cosmetics, perfume, wash and detergent chemistry.

Singapore International Water Week
DHI will be present with a stand at the Singapore International Water Week on 1-5 June 2014. Visit us to learn more about our services in software, consulting and our global training programme.

Courses

QSAR workshop - 7 May, Denmark

IUCLID 5: Training for REACH and Biocide Registration Dossiers – 27 + 28 May, Denmark

GHS - Classification and labelling of chemicals - 12 June, Indonesia

Environmental Hazard Assessment, A general introduction - 11 June, Indonesia

See our remaining courses in Environment and Toxicology (in Danish) on our website.

Contact

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



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