International Workshop on Brominated Flame Retardants

Speech on behalf of Jacqueline Cramer, minister of the Environment and Spatial Planning, delivered by Ton Holtkamp, Director of Chemicals, Waste and Radiation Protection. At the Fourth International Workshop on Brominated Flame Retardants, 25th April 2007 in Amsterdam.

Mister Holtkamp used slides during his speech. Download the slides (pdf, 142 KB).

Ladies and gentlemen,

To her regret, Jacqueline Cramer, the Minister of the Environment and Spatial Planning , was unable to be here in person today to officially open the fourth international workshop on brominated flame retardants. It is my honour to deputise for her. My name is Ton Holtkamp, and I am Director of Chemicals, Waste and Radiation Protection at the Ministry.

As participants here today, you have come from scientific institutions, industry or agencies working in the field of brominated flame retardants. As insiders, you know better than anyone the enormous advantages of flame retardants. Their use stops fires from spreading and saves lives.

As you also know, some of the these retardants can have a negative impact on both public health and the environment. One prominent example is the presence of chemicals in breast milk resulting from a build-up in human fatty tissue. At this time, the industry's attention is focused on Deca, where persistency and bioaccumulation have been reported. As yet, there is no indication of toxic effects.

At the root of the problem is that effects such as these are generally only discovered once the flame retardants involved are being widely used.

Chemicals such as Penta and Octa for example, are already classified as priority substances in the European Existing Substances Programme and this has led to restrictive measures in the Marketing and Use Directive. As for a number of other flame retardants, there are concerns that they might carry risks to public health and the environment, but we do not yet have sufficient data to take restrictive measures.

This is an unfortunate state of affairs, not only for the public and the environment but also for the industry itself. After all, we don't want this issue to reach a point where all brominated flame retardants, some without any justification, are grouped together and stigmatised.

These problems have arisen partly because the responsibility for regulating safe use of these chemicals lies with the government and not with the industry itself. [Slide 1 Opening] The new European chemicals regulation, REACH, which comes into force in June of this year, aims to bring about a fundamental change. REACH will shift the responsibility for adequate risk management for chemical substances, and therefore also for brominated flame retardants, from the government to the commercial sector.

The sheets I will show you contain a lot of details. Given the time pressure I will focus on the outlines and won't mention all the details on the sheets.

[Slide 2 Basic Principles ] The purpose of REACH is to ensure that companies effectively manage the risks attached to the production and application of chemical substances. They will need to highlight those risks by providing information on a chemical's properties, uses and safe levels of exposure. And of course they will need to take appropriate safety measures themselves and advise their customers.

The ultimate aim of REACH is to guarantee a high level of safety in the production and usage of chemicals for both the public and the environment. At the same time, competition in the industry must continue to flourish, or even improve. The REACH system will provide information concerning any chemical available on the European market. And as the responsibilities of the producer or importer will now include the application of these substances, we should see more dialogue between suppliers and customers. This should help the commercial sector get a better overall picture of use right across the supply chain. REACH, then, should lead to better communication about substances from producer right through to the end user.

Beyond these benefits, we shouldn't forget that REACH will also radically streamline current legislation, replacing some 60 existing European directives!

Ladies and gentlemen,

What will REACH mean for you in industry or the research community?

[Slide 3 Main elements-1] This sheet shows the main elements of REACH. I won't mention the details now. To start with, there are three key aspects to consider. Firstly, REACH applies only to chemicals which are produced or imported in the EU in quantities of more than a tonne per company per year. Second, REACH makes a distinction between existing substances that are already on the market and new substances. Under REACH, the former will be labelled phase-in substances and the latter non-phase-in substances. [Slide 4 Roles ] Third, REACH recognises various obligations tied to the role played by companies in relation to a given substance. Companies can perform a number of different roles at the same time and their obligations will differ for each. There are four roles and they are defined as follows: manufacturer, importer, downstream user and distributor. These roles emcompass all organisations working with chemical substances.

[Slide 5 Tasks ] REACH carries a number of requirements for manufacturers and importers of chemicals. The most important ones are:

Registration of substances with the European Chemicals Agency. Depending on the volume of production, manufacturers and importers will need to collect and provide data on the chemical properties of the substances in question.

With volumes of more than 10 tonnes per year, manufacturers and importers will also need to conduct a chemical safety analysis and prepare a chemical safety report based on its findings.

Then, if a substance has been identified as dangerous or if very persistent and very bioaccumulative, manufacturers and importers will be required to draw up a safety data sheet and distribute the information to all downstream users and distributors.

They will also need to provide information on exposure scenarios relating to the use of the substance, and recommended risk reduction measures.

[Slide 6 Main elements-2 ] Manufacturers and importers will need to apply for authorisation when dealing with substances of very high concern. These substances will be listed in annex 14 of REACH. The annex is empty at the moment. The first major risk chemicals will not be recorded in it for another few years. And finally, manufacturers and importers will need to comply with the restrictions set down in annex 17 of REACH, which apply to bringing chemical substances to market and to their after-sales use.

[Slide 7 Time-schedule ] This sheet shows the timetable for the preregistration and registration obligations. For existing substances, REACH has developed a transitional arrangement for their gradual inclusion in the registration process. Depending on quantities, the substance must be registered within 3½, 6 or 11 years of 1 June 2007. To restrict the number of animal tests, REACH will require data and results to be shared. And to that end, pre-registration will be required of all existing substances with the European Chemicals Agency.

The objective of pre-registration is to simplify both cooperation between companies working with the same substance, and the mandatory sharing of data which, as I've said, will allow the number of animal tests to be limited. At the same time, downstream users will be able to see from the list of pre-registered substances whether manufacturers or importers plan to register substances relevant to them.

REACH also has a number of requirements for importers of articles, distributors and downstream users. Given the time pressure I won't dwell on these right now.

Ladies and gentlemen,

[Slide 8 Authorization ] What I do want to emphasise is the vital role the new authorisation system will have under REACH. For highly dangerous substances, this system will work on a not unless principle. This means that from a certain date forward, such chemicals will not be permitted for trade unless authorisation has been obtained beforehand. And this authorisation will take the form of a permit. Under REACH, the substances which will require authorisation will first be identified and then set down in annex 14. After this, companies working with these chemicals must apply for authorisation to use them. While risk factors will be considered in assessing the application, the possibility and availability of alternative solutions will also play a role.

Considering the chemical properties of many brominated flame retardants, you won't be surprised to hear that these substances will be placed on the list requiring authorisation. At least, they will if they're not already subject to other restrictions or measures. Although substitution is not an automatic requirement under REACH, when assessing the applications for authorisation, close attention will be paid to it.

I have allready showed you the timetable for the preregistration and registration obligations on a former sheet. Here is the timetable for the implementation of the main REACH requirements [Slide 9 Time schedule] . The administrative requirement that manufacturers and importers must draw up a safety data sheet and distribute the information to all downstream users and distributors, enters into force at 1 June 2007. Most of the other REACH requirements will enter into force at 1 June 2008.

Now, you and I know that REACH is not a simple piece of legislation. That's why its essential that information is both available and effective. The member states and industry associations can all provide extensive information, and every member state will soon have a dedicated REACH helpdesk. The Dutch helpdesk has been operational since January of this year and already appears to be meeting a real need for support and information. Various industry associations have also set up their own REACH helpdesks.

In accordance with the EU Treaty, enforcement of REACH and the relevant penalties fall within the jurisdiction of the member states themselves and not the European Union. Nonetheless, it's important that the member states work hard to achieve a level playing field. For this reason, the REACH Regulation explicitly calls for a Forum to be established, in which representatives from the member states will meet to align enforcement of REACH as closely as possible and to enable information exchanges.

Ladies and gentlemen,

To conclude: let's come back to brominated fire retardants. Its probably clear to you that REACH will have a significant influence on all facets of the industry's operational management. Responsible Care and Product Stewardship, two programmes which were set up on a voluntary basis by the industry, will both see their mandates and resources extended with the introduction of REACH. And a key effect of the REACH requirements will doubtless be an increased need for external experts, such as those representatives of scientific institutes here today, to assist with the collection and analysis of data for industry. I hope that industry can join with the research community to manage the REACH requirements. [Slide 10 End ] The ball is in industry's court now, and I call on them to take up these responsibilities for the sake of the public, the environment and their own operational effectiveness. They will need to ensure an adequate method of risk management for chemical substances, including the production and application of brominated fire retardants. But the government and the scientific community also have to play their part. We need to stand side by side with the market, armed with information, knowledge and expertise.

I wish you all a successful and productive workshop.

Thank you