EU ZMK's Diary

“Life is ten percent what happens to you and ninety percent how you respond to it.” ~Lou Holtz

The main purpose of this blog entry is to raise awareness among public health experts concerning a new, recently published piece of the EU’s health related environmental law regulating a specific group of dangerous chemicals: the so-called biocides (dangerous chemicals intending destroying/deterring harmful organism) the health dimension is often forgotten of.

(Owner of the photo © Jason Wilson)

Biocidal products are basically non-agricultural pesticides which are useful and necessary for our everyday life and for the safe functioning of healthcare institutions such as hospitals (i.e. cleaning liquids, rodenticides, antibacterial soaps but even drinking water could not be preserved without appropriate disinfectants which are of course biocides). On the other hand, they put not only the environment but also human health in serious danger therefore a very careful human health based approach is inevitable from the EU co-legislators.

The role of the Health sector in the adoption of the new biocide regulation 528/2012/EU

The new Biocide Regulation 528/2012/EU has been published on the 27th June 2012 in the Official Journal which is a good occasion to re-focus the attention of the interested environmental health and public health professionals on the strong connection between dangerous chemicals in general (and more specifically biocides) and public health.

Formally, biocides belong to the environmental regulatory sector. From the Council’s perspective, the Environmental Ministers discussed and adopted the new biocide regulation 528/2012/EU together with the European Parliament (and especially with the ENVI Committee) following the ordinary legislative procedure according to article Article 294 TFEU (ex Article 251 TEC) [1] between 2009-2012.

However, this legal perspective does not mean at all, that the health sector would have been excluded from the process. In the opposite way, under the auspices of the environmental ministries, the representatives of the Ministries of Health of several EU Member States negotiated this regulation. Thus, in a special, hidden way the health sector had a say in the debate with special regard to the fact, that Member States have been designated public health authorities as Biocide Competent authorities in many cases.

Nonetheless, if we take seriously the Health in All Policy (HIAP) approach, we cannot pay enough attention to every single form of threats caused by dangerous chemicals. Health professionals use regularly antibacterial liquids in hospitals to disinfect every available material and to sterilize medical instruments. Furthermore, special soaps are used for washing the hands before serious medical operations. From the perspective of general public health, other form of biocides are essential to fight vector-born diseases since rodenticides and repellents can be crucial to keep away mosquitos, ticks and other vectors. And even one of the most essential components of human life, drinking water could not be preserved without appropriate disinfectants.

It is therefore vital to re-focus the attention of the interested environmental health and public health professionals on the strong connection between dangerous chemicals in general (and more specifically biocides) and public health.

Entry into force

If you realize that biocidal chemicals would be interesting for you/your organisation, save the date! With the exception of transitional measures the new biocide regulation 528/2012/EU will enter into force on 1st September 2013 (paragraph 2 of article 92).

Basic information about the biocide legislation of the EU

The European Union has been establishing a harmonised regulatory common background for biocides based mainly on the Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market, with a view to ensuring a high level of protection for human health and the environment.

Following a long evaluation process, in the light of the gained experiences, the Commission presented its proposal to repeal and replace the old directive by a new regulation. After a 3 years longing ordinary legislative procedure, the new Regulation 528/2012/EU of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (hereinafter referred to as ’the new biocide regulation 528/2012/EU’) has been published on the 27th June in the Official Journal.

In order to avoid overlaps between the existing EU law concerning some aspects of the public health (worker’s health, food, medical devices, etc.) and the new biocide regulation 528/2012/EU, this regulation sets up a detailed list of existing legislation this regulation shall not apply on.

Both the existing and the future legal framework collect the biocidal products into 4 different ‘Main groups’ and into several ‘Product types’ (PTs). These structures are essential to better understand the logic behind the legislation. The Main Groups and PTs are the followings according to the new regulation:

MAIN GROUP 1: Disinfectants (this main group is presented here in a more detailed manner since they might be more interesting for health professionals)

Product-type 1: Human hygiene – Products in this group are biocidal products used for human hygiene purposes, applied on or in contact with human skin or scalps for the primary purpose of disinfecting the skin or scalp.

Product-type 2: Disinfectants and algaecides not intended for direct application to humans or animals – Products used for the disinfection of surfaces, materials, equipment and furniture which are not used for direct contact with food or feeding stuffs.

Usage areas include, inter alia, swimming pools, aquariums, bathing and other waters; air conditioning systems; and walls and floors in private, public, and industrial areas and in other areas for professional activities.

Products used for disinfection of air, water not used for human or animal consumption, chemical toilets, waste water, hospital waste and soil.

Products used as algaecides for treatment of swimming pools, aquariums and other waters and for remedial treatment of construction materials.

Products used to be incorporated in textiles, tissues, masks, paints and other articles or materials with the purpose of producing treated articles with disinfecting properties.

Product-type 3: Veterinary hygiene

Products used for veterinary hygiene purposes such as disinfectants, disinfecting soaps, oral or corporal hygiene products or with anti-microbial function.

Products used to disinfect the materials and surfaces associated with the housing or transportation of animals.

Product-type 4: Food and feed area

Products used for the disinfection of equipment, containers, consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption of food or feed (including drinking water) for humans and animals.

Products used to impregnate materials which may enter into contact with food.

Product-type 5: Drinking water

Products used for the disinfection of drinking water for both humans and animals

MAIN GROUP 2: Preservatives

MAIN GROUP 3: Pest control

MAIN GROUP 4: Other biocidal products

A summarised presentation of the structure is available under the link below, following this basic structure:

General overview of the biocidal legislation of the EU can be seen here

Scope
Obligations of the Member States
Principle of mutual recognition of authorisations
Conditions governing the granting of authorisations
Placing on the market of active substances
Inclusion of a new active substance in the Annex
Cancellation of an authorisation
Modification of an authorisation
Procedure for requesting authorisation
Provisions applicable to a biocidal product that has already been authorised
Exemptions
Role of the Commission
Research and development
Classification, packaging and labelling
Safety measures
Confidentiality
Safeguard clause
Advertising
Comitology

For further information about Chemicals, you may visit Health and Environment Alliance – HEAL’s website.

Application of the new biocide regulation 528/2012/EU to consumer products (the example of washing liquids as potential treated articles)

The new biocide regulation 528/2012/EU is a very complicated legislation. The sooner the interested become familiar with it the better. To illustrate that complexity, EPHA is very pleased to refer to the following case:

A single example may be sufficient to demonstrate the complexity of the application of the regulation in the practice. Let’s take the example of an antibacterial washing up liquid[2] consumer product, where the first action is cleaning and the second one is as a bactericide effect.

There were fierce discussions during the adoption of the new biocide regulation 528/2012/EU about the scope. To consider whether or not such a liquid can be considered as a biocidal product the biocidal product’s legal definition[3] will guide us.

The definition of treated article (point l) paragraph 1. Article 3):

“‘treated article’ means any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products;”

If the liquid doesn’t fit the definition of the biocidal product it can be still considered as a treated article if it contains at least one substance considered as a biocidal product having primary biocidal functions.

“A treated article that has a primary biocidal function shall be considered a biocidal product.”

If the biocidal substance in the washing liquid has a secondary biocidal function, it can be considered as a treated article.

The antibacterial effect of a washing liquid seems to be a primary biocidal function. Another example for biocidal products having secondary biocidal function would be a mosquito net treated by a repellent material. In this case the main function of the net is keeping away the mosquitos by a physical way, and the chemical repellent – biocidal – effects is just an additional effect to make the net even more effective.

[1]the Treaty establishing the European Community (TFUE) and the the treaty Establishing the European Community (TEC)
[2] Nota bene: a simple washing liquid without a biocidal effect (ex. antibacterial) won’t be considered as a biocidal product and the new biocide regulation 528/2012/EU won’t cover it at all.
[3] ‘biocidal product’ means any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active (biocidal) substances with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action (see Definitions, point a) paragraph 1. Article 3)

I remain at your disposal.

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Related earlier EU Hemicycle updates:

17. Thought Starter about the Role of the REACH Regulation(EC/1907/2006) as regards Chemicals and Dangerous Substances

12. Chemical Coctails and the Way Forward in the Light of the Scientific and Legal Difficulties

Zoltán MASSAY-KOSUBEK

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