EU ZMK's Diary

“Don’t let something that doesn’t matter cause you to lose something that does.” ~Phil Torcivia

The problem of Chemical coctails still emerges and can be considered as a relatively new field of chemicals. It is quite easy to understand why are chemical coctails in the very center of interests of scientific and legal professionals and why are they one (1.) of the three most dangerous categories of chemicals – in line with Endocrine Disruptors (2.) and Nanosubstances (3.) – where the existing framework of the law of the Union – including the famous REACH regulation – does not provide an efficient level of protection of health and environment.

Let’s assume that neither substance ‘A’ nor substence ‘B’ have harmful properties alone. Nonetheless, if they are mixed with each other, it may happen ex. that above 100 C this new coctail became explosive. Or ‘simply’ they will have corrosive, carcinogen, mutagen or other harmful effects which do not occur if the components are separated. Additionally, if we use instead of either substance ‘A’ or substance ‘B’ a ‘mixture’ (which contains in itself already several substances) the possibilities of occuring potential harmful effects of such chemical coctails would emerge accordingly.

With this basic, theoretical example it is obvious why shall we take those ‘chemical coctails’ seriously and in that matter, the precautionary principle must be applied doubly.

I can clearly remember that under the Hungarian Presidency in the first half of 2011, Denmark – who was always a flagship of new environmental initiatives – put forward at ministerial level a proposal aiming at accentuating the relevance of this problem in the Council. So, it is not a surprise that the Commission is likely to present a new strategy paper on chemical combination effects in this May, under the Danish EU presidency, followed by other initiatives in 2012 and in 2013.

The European Parliament is well aware of the problem and closely monitors this process. May I draw the attention to its resolution of April 20 on the review of the 6th Environment Action Programme and the setting of priorities for the 7th Environment Action Programme . In this legal text, EP gives clear political indications under the title ‘Environmental quality and health’, in point 44., fourth subparagraph, as follows:

“The Europpean Parliament
(…)
44. Takes the view, given that poor environmental conditions have a substantial impact on health, involving high costs, that the 7th EAP should notably:
(…)
– provide for the development of specific measures relating to emerging human and animal health threats, currently not sufficiently addressed, to examine the effects of new developments on human and animal health, such as nanomaterials, endocrine disruptors and the combination effects of chemicals, on the basis of scientific studies and commonly accepted definitions, where available;”

Obviously, any kind of new proposals will be based on existing scientific evidents which are collected in the recent Commission’s 2010 study which serves as a basic document for further legal steps.

We shall bear in mind that Europe and the EU is often considered worldwide as a leading regulator in the chemicals sector who is strongly committed to discover new pathways in that specific area with serious health, environmental and economic effects. The REACH regulation is one of the cornerstones of this leadership-role since the global influence of REACH is clearly visible: other important countries (ex. Chine, Thailand) are interested therein. However, any kind of such advantage in the chemical sector can be easily overshadowed by the very fast scientific development.

Taking into account two decisive factors, namely that
1. – the chemical sector is strongly dependent on the latest scientific data,
and
2. – the EU still spend less for Research & Development than its global partners,

it is not a surprise that the EU’s leading role is in danger in that matter, too. And since the field of chemical coctails is such an identified territory where it is already stated that the EU does not meet the required protective level of regulative framework, this circumstance may be – among other factors – a signicficativ competitive disadvantage in spite of other global actors/countries.

Thus, it is of utmost importance that the above mentioned paper be placed on the table as soon as possible (in May).

The perspectives of the future coctail-regulation are not so optimistic, either. Not only because of the scientific complexity of the territory but also because of the fragmented legal framework. The law of the Union is very complex in that regard, and several pieces of legislation regulate the dangerous chemicals (REACH, CLP, Biocide regulation, PPP regulation, waste legislation etc.). From a legal point of view it makes a difference which legal way will be choosed. Either to implement all new element in every single existing regulations/directives or to draft a completely new legislation dedicated to regulate coctails (and endocrine disruptors and nanosubstances).

Conclusion

The EU legislators (COM, Council, EP) are not in a favorable position: there is a need for a new, stricter regulation in order to reach a higher level of protection of health and environment and to maintain competitivness in the global world on the one hand, and there are the above mentioned special scientific and legal complex issues on the other.

Although the situation is complicated and difficult, the example of the succesful adoption of the new biocide regulation clearly demonstrates that with political will and with a lot of flexibility, ‘impossible’ can be deleted from the European stakeholders’ dictionary.
Those who are interested can read this Bloomberg article about this issue:

Risks of Chemical Mixtures, Endocrine Disruptors, Nanosubstances

I remain at your disposal.

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Zoltán MASSAY-KOSUBEK

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Comments

  1. The original comment has been made to the earlier version fof the blog and it has been copied without any changes from here: http://massay.kosubek.zoltan.dinstudio.com/diary_1_17.html

    “5/9/2012 10:46:14 AM – Desmond WAIGHT, info@dangoods.co.uk, http://www.dangoods.co.uk
    Is “chemical cocktail” just another name for a deliberate mixture (or substances)that has under existing law to be assessed by the supplier for any aynergistic effects (though predictive methods are largely unknown) OR does it describe the exposure to a number of different substances (perhaps some slreary in mixtures) by humans accumlated during the course of their work and non work activities – which can be very variable. Eg a worker may get exposed to limonene in his private life and a sensitiser in his work life that together may result in triggering of their sensitivity to one of these chemicals.

    Perhaps a definition of “chemical cocktail” is needed before we go any further with discussions”

  2. The original comment has been made to the earlier version fof the blog and it has been copied without any changes from here: http://massay.kosubek.zoltan.dinstudio.com/diary_1_17.html

    “5/9/2012 11:45:09 AM – Zoltán MASSAY-KOSUBEK, massayzoltan@yahoo.com, massay.kosubek.zoltan.dinstudio.com
    Dear Desmond,

    thank you very much for your valuable comment.

    Yes, the most important thing before starting a discussion is to lay down the limits of the exchange of view.

    As a lawyer, I prefer to be fixed to the legal text since it is the mandatory guidance for every concerned stakeholder (including suppliers who are obliged to adress some mixtures).

    Currenty, according to the CLP regulation:

    ‘mixture’ means a mixture or solution composed of two or
    more substances;

    I admit that it is a very large category. Theoretically, both of the mentioned cases can fall under its scope, nevertheless, the legislators intention would probably wanted to cover the first option.

    In my opinion, the new, appropriate definiton of “chemical coctail” would resolve this question and it may be considered, as a sub-category of the already existing mixtures.

    However, the second mentioned option would extremely expand the scope of the legislation and the potential nummber of coctails. It is up to the legislator to decide whether the desired high level protection of health and environment can be achieved with such a large scope and whether it is an economically viable and required solution.

    Very hard, political decisions to be made.

    May I give you the example of the definiotn of nanomaterials, where no scientific consesus was reached at that time (in 2011).
    There were namely a long-running discussion before the adoption of the new biocide regulation if the latest, current definition of nanomaterials shall have been included into the legal text or – with regard to the always changing scientific circumstances – or it was better if only a reference would have been inserted into the legal text.
    This second solution seemed better from scientific aspects but became very problematic from legal point of view, since the adaption of the Commission’s law would have mean the ‘automatic’ modification of the regulation which can be modified only through ordinary legislative procedure. It was not an easy situation and finally, a political compromise had been reached.

    Hence, to be conclude, I fully agree to the need of an appropriate definiton of ‘chemical coctails’ so we have to wait the paper to come out this month and consider if it can be formulated by consensus.

    Zoltán MASSAY-KOSUBEK
    ► massay.kosubek.zoltan.dinstudio.com”

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