Health and Safety
Executive / Commission
Biocides &
pesticides
These Fact Sheets provide briefings for manufacturers, suppliers and users of active substances and biocidal products to keep you up to date with the implementation of the Biocidal Products Directive (Biocidal Products Directive) 98/8/EC and the Biocidal Products Regulations 2001
Fact Sheet 11 is not a revision of Fact Sheets Nos.1-10 but instead provides supplementary information and advice. If you would like a copy of earlier Fact Sheets please contact us at the address given at the end of this Fact Sheet, or download them from our website, details of which are given at the end of this Fact Sheet.
In response to the questions raised at the recent Biocides Roadshow in London, HSE has looked at two specific issues related to the first biocides Review Regulation (1896/2000) and can provide the following update:
Q. Where a company notifies an active substance for use in several product
types, do they have to prove that a product of each product type was on
the market before 14 May 2000?
A. The European Chemicals Bureau (ECB) has confirmed that they agree with
our opinion that it is only necessary to show there was a single product
on the market containing that active substance, and that it is not
necessary to prove there was a product on the market for each product type.
(the relevant text of the Regulation is at Annex II, para 3. of 1896/2000)
Q. Where a company manufacturing a biocidal product makes a notification,
do they require a letter from the active substance manufacturer designating
them as their sole representative?
A. Article 4 of the Regulation sets out those who may make notifications.
For a company to decide whether it can make a notification, and whether
it needs to gain a letter of designation from someone else, the company
must consider the text of Article 2: the situation depends on whether
the company is producing/manufacturing a product or an active substance,
and whether this occurs within the EC or outside of it.
For the particular case where a company is manufacturing a biocidal product
within the EC, they may notify the active substance and they do not
need to be designated sole representative by the manufacturer of the active
substance.
(Note that the Regulation permits a product manufacturer to notify,
it is not a requirement/obligation to notify. In many cases a manufacturer
of the active substance may make a notification covering the product type
of interest to the product manufacturer.)
A revised draft of the Second Review Regulation has recently been circulated by the EC to Competent Authorities. This will be discussed at the 10th meeting of the Competent Authorities on 15th March 2002.
The Competent Authorities' meeting in December 2001 discussed the TnG on the inclusion of active substances in Annex I. The main point for discussion was the text for corrosivity, irritation and sensitisation. These were areas where Industry has reported difficulties. A modified text for sensitisation, which was acceptable to Industry, was tabled and the meeting agreed that the principles would be applied to corrosivity and irritation.
A revised text of the TnG has recently been circulated to Competent Authorities. It is intended that agreement to its use in draft form will be by written procedure (i.e. sent to Member States for written agreement rather than discussed at a specific meeting).
The TnG on the common principles and the authorisation of products was discussed at a Technical Meeting, held at the European Chemicals Bureau, on 24 January 2002. The EC had circulated a further version (version 7) for this meeting. A further version should be available for the next Technical Meeting scheduled for 6-8 May 2002.
Work was started, in 1998, on the production of a standard format for Industry to use when submitting dossiers supporting applications for the inclusion of active substances in Annex I. The EC has been modifying its IUCLID software to enable such dossiers to be prepared and submitted using IUCLID.
Whilst IUCLID will be used for the submission of dossiers, the study summaries of key studies will be prepared on Word-based templates that will then be attached to IUCLID. Guidance on the selection of key studies is being developed by the EC. We anticipate that this approach will be used for dossiers on wood preservatives and rodenticides that must be submitted by 28 March 2004.
The EC is initiating activity to implement the Biocidal Products Directive Article 17 on Reseach & Development activities, especially in relation to experiments where there is a release into the environment. Member States have been asked to send to the EC details of how they have implemented the requirements in national legislation.
The UK has made proposals for these activities and has discussed them both within Government and with Industry. We will be seeking the views of the Biocides Consultative Committee, hopefully at its next meeting.
A second contract to develop further environmental exposure scenarios for biocides has been awarded to TNO in the Netherlands.
The final report on the Pilot Review Project has been made available to Member States. This project progressed two active substances through the review processes to test the processes and make recommendations for further work. The report makes a number of recommendations, in particular on the need to develop further risk assessment tools and in ensuring that systems are available both for applicants to prepare and present dossiers, and for rapporteur Member States to evaluate them.
At the meeting of the Competent Authorities in December 2001 there was some discusion about the difficulties some Industries may have in supporting active substances that are considered to have either minor or essential uses as biocides. Essential oils, pheromones and Product Type 22 (embalming and taxidermy fluids) were mentioned as examples. Whilst the EC is clear that there are no derogations under Biocidal Products Directive for such uses, it does appreciate that there may be difficulties and that an alternative way forward may need to be found. With this in mind, the advice that the EC is giving is that active substances with such uses as biocides should at least be Identified before 28 March 2002. After this date the EC would look at this issue again. The best option is still to notify in case it is not possible to agree a different way forward.
At the meeting of the Competent Authorities in December 2001, the EC tabled a paper outlining their interpretation of Biocidal Products Directive Article 12 on data protection. There was no discussion of the paper and Member States were asked for comments by 31 January 2002. The periods of data protection proposed in the paper are more generous than the UK had previously envisaged. In responding to the EC, the UK has welcomed the desire of the EC to clarify the rules and has asked the EC to clarify the background and the reasoning behind their proposals. The paper will be discussed further at the Competent Authority meeting on 15 March 2002.
The Biocidal Products Directive concerns the placing on the market and use of biocidal products within the EU. The Biocidal Products Directive does not apply to biocidal products that come within the scope of other EU Directives already in place when the Biocidal Products Directive was implemented in May 2000. These other Directives are all listed in Article 1 of the Biocidal Products Directive. In general, if a product comes within the scope of one of these other Directives it cannot come under Biocidal Products Directive as well.
At the recent Competent Authority meeting in Brussels (December 2001) papers were presented on the following scope issues:
3 key points were raised:
1 - Disinfectants used on human and animal skin - disinfectants used on skin for general hygiene purpose would be considered to be biocides, providing no therapeutic claims are made, and that a disinfectant intended or demonstrated to have medicinal effects would be considered to be a medicinal product.
2 - Repellents with no killing effects applied to human and animal skin - these are considered to be within the scope of the Biocidal Products Directive.
3 - Products used to kill external parasites - scope will depend on the use and/or claim, generally products used on housing and bedding are within the scope of the Biocidal Products Directive, products used on skin with a therapeutic claim would be medicines.
There was broad agreement to the text tabled by the Commission. After minor amendments the text will be published on the ECB website and can then be used for general guidance.
This whole area is somewhat complicated, the problem being that there are a number of Directives involved that impact upon the different processes involved in the milking industry:
Disinfectants used in treatment and processing areas are excluded from the Biocidal Products Directive as they are within the scope of the directive 92/46/EEC (health rules for the production and placing on the market of raw milk, heat-treated milk and milk based products).
Disinfectants used on milking equipment or in the pipework used in production areas or in transport to the treatment plants are within the scope of the Biocidal Products Directive.
In the UK teat dips and udder washes are regulated as if they were Veterinary Medicines. The Commission intends to overhaul the Directives taking the line that one of the requirements after reform will be that all the products used should have been authorised under the Biocidal Products Directive. Therefore active substances used in products for these purposes should be identified/notified under the Biocidal Products Directive First Review Regulation.
Cosmetics with secondary biocidal claims (for example a sun cream containing an insect repellent), are outside the scope of the Biocidal Products Directive providing the primary function of the product is cosmetic and that it complies with the requirements of the Cosmetic Products Directive (CPD).
Preservatives used in cosmetics are excluded from the Biocidal Products Directive.
There was no overall agreement to the paper at the Competent Authority meeting, however the UK did support the paper as tabled and the Commission made it clear that it had been agreed with legal services.
It was agreed that the approach to such articles (e.g. mosquito nets containing insect repellents, socks, mattress covers) should be the same as that for treated articles under the EU new chemical substance legislation. This will mean that the 'article' should be seen as the delivery mechanism for the biocide and can be considered to be a biocidal product within the meaning of the Biocidal Products Directive and so is within scope. So the active substance used in the article should be supported under the First Review Regulation.
The Commission has agreed to amend the In Vitro Diagnostic (IVD) Medical Devices Directive and to adding it to Article 1.2 of the Biocidal Products Directive thus formally exempting from the Biocidal Products Directive biocides used solely in IVDs. Thus the Commission agreed that such biocides used solely for this purpose do not need to be supported under the First Review Regulation.
This is the generation of a biocide from other chemical 'precursors' at point of use, for example, chlorine, formaldehyde and bromine generators.
The general principles are : biocidal agents generated in-situ from supplied precursors are in general deemed to be within scope and have to be identified/notified. Precursors that are also active substances will also have to be identified/notified. Where the precursors are not active substances they do not require notification, but the resulting biocidal substance does, and the final Annex 1 etc. entry will be a composite one, referring to both the proximate active and the precursors.
This article aims to provide you with the most up-to-date information available on the progress of the Biocidal Products Directive. However you must be aware that the important decisions are taken at a European level following discussion between Member States and the European Commission; they are not taken solely by HSE. This article indicates the areas where we understand that agreement has been reached, and where there continue to be uncertainties.
In general the Commission's view was that if there continued to be uncertainty over whether or not to notify an active substance because of scope borderlines then a company should notify it now: Article 4.4 of the Review Regulation would permit a notifier to withdraw from the review programme if the use was subsequently deemed to be outside the scope of the Biocidal Products Directive.
The Directive is implemented in Great Britain by the Biocidal Products Regulations 2001 (SI 2001/880), which came into force on 6 April 2001. Separate legislation is required for Northern Ireland, and the Biocidal Products Regulations (Northern Ireland) 2001 (SR 2001/422) came into operation on 16 January 2002. Both sets of regulations are available from HMSO, priced £7.50 and £7.00 respectively. They can also be downloaded from the HMSO website at www.opsi.gov.uk
The Biocides Consultative Committee (BCC) is an independent advisory committee which will provide the UK Competent Authority with advice on the evaluation of biocidal products under the Biocidal Products Regulations (BPR). The BCC comprises an independent Chair and independent expert members. There are also lay members to represent consumer, environmental and employee interests. The Committee can also call upon a 'usage pool', whose members have a declarable interest in the biocides industry, when their specialist input is required.
The BCC held its inaugural meeting on Friday 26 October 2001. In the absence of any applications for new active ingredients, the Committee used the inaugural meeting to focus on establishing the terms of reference and the code of practice under which it would operate. The terms of reference agreed at the meeting are
to advise the UK competent authority (CA) on biocides and scientific matters in relation to the Biocidal Product Directive (Biocidal Products Directive) and Biocidal Product Regulations (BPR), in particular, the UK CA's negotiating position at the meetings of the EU Standing Committee on Biocides for:
The BCC also discussed the issue of openness and the possibility of some of their future meetings being open to the public. Members agreed that agendas and minutes should be made public, via the Internet and it hoped to initiate web pages in the near future.
Two half day Roadshows were held in January 2002 in Bootle and London. The Roadshows updated Industry on Scope, the Review Regulations, other EU issues and implementation in the UK. 118 people attended the 2 Roadshows and we received feedback from 42 delegates, which included:
People who attended the Roadshows have been emailed a copy of the MS Powerpoint presentation and a copy of the Feedback from delegates who attended. If you would like a copy of the MS Powerpoint presentation, please send your e-mail address to Pauline Stenhouse at pauline.stenhouse@hse.gsi.gov.uk
The HSE intends to hold an Industry Seminar to cover aspects both of the biocides legislation and the existing national legislation for pesticides (the Control of Pesticides Regulations). This will be a one day event, hosted in Liverpool, and will give HSE the opportunity to bring delegates up-to-date on issues, whilst also providing a forum for discussion and allowing delegates to put their questions and concerns to HSE staff.
This was supported at the last meeting of the Ad Hoc Industry Group at which Industry were invited to provide topics to include in the seminar. The Seminar will be held in October / November 2002 rather than when originally proposed in April-May.
Topics to be discussed at the Seminar will probably include updates on -
but are yet to be finalized, and if you wish to send suggestions for topics for the seminar, please send them to BPU at the address at the end of this Fact Sheet, or e-mail to biocides@hse.gsi.gov.uk. Further details of the seminar will be given in the next Fact Sheet.