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Denmark defies EU with planned ban on phthalate chemicals

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Published 27 August 2012, updated 12 September 2012

Danish Environment Minister Ida Auken has decided to ban four industrial chemicals linked to disrupting the human endocrine system, pushing Denmark ahead of the European Union which has already started a process of phasing out phthalates.

Auken said she would introduce a ban this autumn on DEHP, DBP, DIBP and BBP phthalates.

Phthalates are chemical substances which are used to make plastic soft and more flexible. They can be found in everyday products such as rubber boots, oilcloths and vinyl flooring and some of them have already been banned in Europe for use in children's toys.

In deciding the ban, Auken is defying EU regulation in the area. In Spring 2013, the European Commission is due to look into further action in the area of endocrine disrupters that could lead to tougher regulation of phthalates.

Some phthalates with low molecular weight - namely DEHP, DBP, DIBP and BBP - have been linked to reduced sperm count, causing male sterility. They are also being accused of pushing young girls into puberty too early and causing liver cancer in rats.

"The Danish Environment Ministry has enough documentation so we feel now is time for action," Auken told EurActiv. 

"The EU will look at this in spring, and we know how long it will take before everyone agrees on what to do. It has to go through all the institutions, and then it has to come into force. It can take a really long time so I don't think that Denmark should wait for that when there are such clear [risk] indications in this area."

"Therefore I take these phthalates off the market," the Danish environment minister said in a telephone interview.

Risking EU court case

Auken also said she considered the EU regulation concerning phthalates "completely inadequate".

"This is an area in the EU which is unregulated, so therefore I think it's correct to do this and let Denmark move ahead," the environment minister said.

The EU’s 2006 REACH regulation requires chemical manufacturers to register the 100,000 or so substances currently on the market and submit them for safety screening and subsequent authorisation. Those that are considered to pose an unacceptable threat to human health or the environment may be phased out and eventually replaced.

Auken said the European Commission on 4 June sent a detailed statement about the Danish Environment Ministry's decree, which showed that there is a disagreement between Denmark and the EU about how REACH should be interpreted.

This means Denmark could risk going to court with the EU over the ban of the four phthalates.

"Of course I don't hope there'll be a case, but if there will be one then I'm ready for it," Auken said, adding that she has academic material as evidence, and that she has consulted the Danish government's specialised Legal Committee which has ensured her she would win an EU court challenge.

Auken said she sees two barriers in the EU regarding chemicals regulation. First, she thinks there has been a lack of willingness to look into the "very complicated" area of endocrine disrupters. Secondly, it's not a secret that "there is strong lobbying in the EU from the chemicals industry, and we will probably hear more from them regarding this area."

Annoyed industry sees a ‘political stunt'

Industry groups have voiced surprise at the move. PVC Information Council Denmark, an organisation under the umbrella of the European polyvinyl chloride industry, said the ban is unnecessary as the most dangerous phthalates were being phased out anyway.

"It has been said by EU experts in Denmark that this is a political stunt and we don't disagree with that," director of PVC Information Council Denmark Ole Grøndahl Hansen told EurActiv.

"The consumption of the phthalates, which she [Auken] attacks, has been markedly on the decrease and they are on their way out in the EU. So why make this noise? It's annoying," Hansen said.

Hansen said that while some phthalates have been classified as dangerous, others have not. Within the last 10 years there has been a marked decrease in using dangerous phthalates in products, he said. And there are many alternative agents so it's possible to completely avoid phthalates in soft plastics such as PVC.

"We have all agreed that we [should] follow what REACH has planned, how the phasing-out should be done, but she [Auken] can't even wait six months," Hansen said.

The industry director highlighted that the decisions about phthalates in the EU are based on scientific risk evaluations which the member states' top scientists have discussed for years. Therefore, in a potential court case, the Danish environment minister would have to argue scientifically against all the member states' researchers' conclusions, Hansen said.

"It will be very difficult for Ida Auken to go through with this in the EU. She would have to prove that phthalates are more dangerous for Danes than for other EU citizens," Hansen said.

Positions: 

[UPDATE]: Maggie Saykali, from the European Council for Plasticisers and Intermediates (ECPI), a trade association representing phthalate manufacturers, reacted to EurActiv's story on the planned Danish ban.

She indicated that phthalates were mainly used in durable applications such as electric cables, floor covering, roof membranes, pool liners and coated fabrics.

"I am not aware of their use in detergents and I don’t see what benefits they will bring to this application," Saykali said. "As for cosmetics (shampoo, nail polish, hair spray and others), only two non-regulated phthalates (DEP and DMP) are used in Europe nowadays. DBP and DIBP are not allowed in Europe as the EU Cosmetics Directive restricts the use of CMR substances in cosmetics." CMR stands for  carcinogenic, mutagenic or toxic for reproduction.

Regarding toxicity, she insisted on the distinction between low phtalates – "which were indeed found to be reprotoxic in animal testing" – and high phtalates. The latter, she said, have been "extensively risk assessed by the EU and were found to be safe in all of their current uses."

Saykali acknowledged however that some low phtalates represented a health risk for animals, but that no causal link with humans had been established.

“Four low molecular weight phthalates, namely DEHP, DBP, DIBP and BBP, do cause reduced sperm counts, testicular atrophy and structural abnormalities in the reproductive systems of male test animals and some studies also link these four phthalates to liver cancer in rats," she said. "With respect to the reproductive effects, no effect levels have been identified and no causal relationship between these effects and humans have been reported."

"DEHP has been safely used in medical applications for over 50 years and has contributed to saving millions of lives. With respect to liver cancer in animals, extensive research has shown this to have no relevance for humans”.

Next steps: 
  • Fall 2012: Denmark to announce ban on four phtalates - DEHP, DBP, DIBP and BBP.
  • Spring 2013: European Commission to review endocrine disruptors.
  • End 2013: Danish ban on DEHP, DBP, DIBP and BBP enters into force.
EurActiv.com

COMMENTS

  • What a lovely surprise!! A politician with balls!! Ironically, a woman (reminds me of Thatcher in Britain - she too was the only one with balls proving what a load of eunuchs seem to enter politics these days throughout Europe).
    If she believes that these products are dangerous and that the EU's vested interests seem to be more corporatist than in favour of protecting people, then she is absolutely right to take this action. Sadly, the eunuchs in Britain could only see fit to implement the Working Time Directive in its gold-plated edition to the detriment of patient care in the NHS by forcing doctors to only work a limted number of hours when we had had a tried and trusted system.

    By :
    Don Latuske
    - Posted on :
    27/08/2012
  • The DK ban will actually take effect in late 2013

    By :
    Marcus
    - Posted on :
    27/08/2012
  • If you ask me, Denmark is having the equivalent of a childish tantrum.

    What this article fails to report is that Denmark already tried to propose regulation of these 4 phthalates in combination via the officially-accepted EU channels (i.e., Denmark submitted a Restriction proposal under the REACH Regulation in late 2011). That proposal was shot down by the European Chemicals Agency's responsible committee of risk assessment experts (appointed by Member States like Denmark), because the proposed measure was deemed inappropriate for reducing risks to human health and the environment. Why? Because it is unnecessary. Exposure to these 4 phthalates has already fallen significantly in recent years, and thanks to other REACH-related initiatives already under way this trend will continue.

    Denmark tried the official channels and the experts shot them down. So now they proceed with a unilateral ban in that's limited to their country. The response is unnecessary, since Denmark has next to no chemicals industry. More importantly, it may quite possibly be illegal, since under EU law the Danes are supposed to go through REACH as the accepted channel for regulating chemicals.

    More reading here: http://echa.europa.eu/en/web/guest/view-article/-/journal_content/926431e7-3a71-4f06-b22c-9c6b54966df3
    and here: http://echa.europa.eu/documents/10162/77cf7d29-ba63-4901-aded-59cf75536e06

    By :
    Oli
    - Posted on :
    28/08/2012
  • Bravo Denmark,we love you-for so many reasons.
    The facts:
    There is enough evidence that Phtalate are toxic ,proof :the ban for children use has been decided.
    The discussion lasts YEARS and could last years also in the future.
    DK has the right to have the individual oppinion on the risks involved.
    DK has the duty to protect first its own population -even if any meassure might be strong or inadequate !- the principle of " primum non nocere " has priority.
    The principle to protect its population has higher priority then the obediance to uniform action in the EU.
    This applies specially then when DK already tried to use the "normal " route through REACH -without success!
    Would not the commonsense oblige us to ban some supposedly toxic substance from use until there is positive and valid evidence of its harmlessness ?
    This even more as these chemicals are not indispensible,really important but are a sort of luxury ?
    DK produces no PVC ,so the harm to industry is not big,but it can control the imports.

    By :
    ivanka
    - Posted on :
    29/08/2012
  • Dear Sir,
    please be so kind and provide the information on phthalates can be used in human medicinal products with limit.

    Regards
    Alka

    By :
    alka
    - Posted on :
    08/10/2012
  • Alka: 'Medicinal products' are drugs/pharmaceuticals. Nnot sure why phthalates would be intentionally used at all...are you perhaps thinking of medical DEVICES?

    By :
    Oli
    - Posted on :
    08/10/2012
  • Dear Sir,
    I would like to clarify.there are six phthalates which are baned in EU with limit more than 0.1 %. But if any excipient e.g. Hypromellose Phthalate which is monophthalic and is official in ph eur. can we use in medicinal product as coating excipient? pls. provide clarity as i am not getting any limits or MRL (Maximum resdual Limit) for Monophthalics e.g. HPMC pthalate.

    regards
    Alka

    By :
    Alka
    - Posted on :
    08/10/2012
  • Hello again Alka. I'm afraid I'm still not quite following you. You appear to be talking about medicinal/pharmaceutical products (i.e., drugs) which are in my opinion NOT affected by this Danish ban. This 'ban' (a 0.1% limit on the phthalates) applies only to articles. Medical DEVICES are articles but drugs are for the most part not devices.

    I do not know much more about medicinal products, unfortunately but I am quite confident that they are not affected by this or the REACH provisions on phthalates, because:
    (a) Medicinal products are not articles, and
    (b) Even if they were articles, medicinal products are exempt from REACH

    By :
    Oli
    - Posted on :
    08/10/2012
  • Dear Oli,
    Thanks for the reply.
    yes, am talking about medicinal products containing drug .e.g. omeprazole Tablets. I am looking for the guidline for 'use of phthaltes in Medicinal product for Human use'. i hope i clarified. could you pls help.

    Regards
    Alka

    By :
    Alka
    - Posted on :
    08/10/2012
  • Alka, no I'm afraid I can't help with regard to medicinal products as I do not work in this area. Note that you should not be shy about sending an enquiry email to the European Medicines Agency and/or DG SANCO for questions like this. The answer might be a simple email away and will certainly be more reliable than whatever you read on internet pages like this. I would also check the European Pharmacopoeia for any harmonised standards or monographs about hypromellose phthalate in medicinal products. Good luck

    By :
    Oli
    - Posted on :
    08/10/2012
Denmark's Minister for the Environment Ida Auken
Background: 

Phthalates are a group of industrial chemicals used to make plastics like polyvinyl chloride (PVC) more flexible or resilient.

Phthalates are nearly ubiquitous in modern society. They are found in, among other things, toys, food packaging, hoses, raincoats, wall coverings, lubricants, detergents. They are also found in cosmetics such as nail polish, hair spray and shampoo, although some have been banned in Europe for such use.

Some phthalates have been found to disrupt the endocrine system, leading to bans across Europe for use in children's toys for instance.

Several phthalate compounds - DEHP, DBP, DIBP and BBP - have been linked to reduced sperm counts, testicular atrophy and structural abnormalities in the reproductive systems of male test animals, and some studies also link phthalates to liver cancer in rats.

Phthalates, like other chemicals, fall under the EU's REACH regulation, which was adopted in 2006. The regulation requires chemical manufacturers to register the 100,000 or so substances currently on the market and submit them for safety screening and subsequent authorisation (>> read our LinksDossier).

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