Short impact assessments - Biocidal Products Regulations 2001 (BPR)

Description of the intervention:

A Statutory Instrument amending the Biocidal Products Regulations 2001 (BPR), in order to implement a Directive amending Directive 98/8/EC concerning the placing of biocidal products on the market as regards the extension of certain time periods.

Objectives:

The amending Directive has as its objectives:

• Extending  from 14 May 2010 to 14 May 2014 transitional period during which existing active substances will be reviewed and considered for inclusion in Annex I of the Biocidal Products Directive 98/8/EC (BPD), to allow existing active substances and the biocidal products they are used in to remain on the market pending the outcome of the review;
• Extending data protection by the same period for data submitted under the BPD;
• Providing for a further extension (limited to two years) by Comitology decision of the transitional period & review programme if needed

We will also take the opportunity to amend the BPR to:

• Amend the definition of "placing on the market", which unintentionally deviates from that used in the BPD and has created an ambiguity that industry has been seeking to exploit for the storage of unauthorised biocidal products for supply outside the European Customs territory;
• Correct an unintended effect of the 2007 amendments to the BPR that prevents a Provisional Authorisation/Registration being granted in the initial stages for products containing both new and existing active substances, contrary to the intentions of the BPD to encourage innovation;
• Fulfil our commitment to bring two of the deadlines by which industry must submit applications under the GB product authorisation procedures into line with other MS. This is set out in agreed guidance in a European Commission document on the harmonised timelines and procedures to be followed by MS, the Commission and industry following the inclusion of an existing active substance into Annex I of the BPD
• Make a small adjustment to the mechanism for switching off the existing legislation (the Control of Pesticides Regulations 1986 - COPR) once the BPR take effect, for the specific circumstance where someone buys a chemical that is not marketed as a biocide and then uses it as a biocide in their own home

Calculation of costs:

The proposed amendments will not bring any additional costs to industry, nor will they produce any savings, since these are simple amendments to allow the status quo to continue for a further 4 years. There will be an administrative cost to HSE of consulting on and bringing into force the Statutory Instrument amending the existing legislation, and this is estimated to be no more than £50K in 2009/10.

Impact on industry (including any effect on the Admin Burdens Baseline):

The changes will affect almost exclusively only those already in the biocides/pesticides systems, who have notified their intention to support active substances through the review or registered an interest in biocides with HSE, including the many SMEs within the biocides industry.

The potential loophole created by the anomalous definition of "placing on the market" is closed.

Applications for product authorisation and mutual recognition (which have not yet begun to be submitted) will have to be sent in between 1-3 months earlier than previously allowed.

Benefits (quantified where possible):

The scope of the BPD is very wide, covering 23 product types including disinfectants for home and industrial use; preservatives for manufactured and natural products; non-agricultural pesticides for use against insects, rodents and other vertebrates and specialised products such as embalming & taxidermist fluids and antifouling products. Extending the transitional deadlines will ensure the benefits described in the RIA for the 2001 Regulations that these Regulations are amending will be realised.

Industry wishing to place innovative new products on the market will be able to apply for a PA/PR without having to wait until all existing active substances have been listed on Annex I of the BPD.

The GB product authorisation procedures will be more closely harmonised with those of other MS.

Industry will have greater clarity on when storage for consignment out of the European Customs territory constitutes placing on the market.

Consultation:

This approach has been discussed with HSE’s Chief Economist and the Better Regulation Team.

Chief Economist's comments:

I am satisfied that an appropriate level of analysis has been employed for this short IA: the amendment to the BPR will bring very limited costs, and benefits which are real but cannot be quantified.

Recommendation:

That based on proportionality, a full impact assessment is not produced.

Signed:..........................
Date: …21 July 2009…
HSE’s Chief Economist