UK CA Renewal Evaluation Strategy

Trim 2016/415852

CREOSOTE

UK CA Renewal Evaluation Strategy

Background

We, as the UK Competent Authority, have agreed to act as the evaluating Competent Authority for the Renewal of the biocidal active substance, creosote, in PT8.

We will evaluate, as appropriate, all relevant new information that is submitted as part of the Renewal Application. We will also instigate a reconsideration and update of the current harmonised classification. However, there are a number of issues that in our view are not clarified by current existing guidelines and Regulations. These issues centre on the fact that creosote is already known to meet the BPR (528/2012) exclusion and substitution criteria (Articles 5 and 10, respectively).

Issues

Creosote is a CMR, a vPvBT, and meets the current criteria for endocrine disruption. It was included in Annex I of BPD (98/8/EC) based on the necessity for its use in several Member States and the apparent lack of suitable alternatives. There are some safe product uses; however other uses have been Authorised on the basis of derogations under Article 19(5).

We do not consider it necessary to re-evaluate those uses that failed previous risk assessments conducted either at first approval (BPD Inclusion) or more recently at product authorisation, as we, and the applicant, are of the view that new guidance or models will not improve the situation. This position is aligned with that for the renewal of the anticoagulant rodenticides (AVKs).

However, we are of the view that it is necessary to reevaluate those uses previously determined as safe. This will be carried out ‘in the light of scientific and technical progress’, and will take into account new information, guidance, exposure scenarios etc.

As creosote meets the exclusion criteria, an examination against Art 5(2) will be made for each use that the applicant has applied for. This also is aligned with the renewal of the AVKs and likewise, proposals for appropriate risk mitigation measures will be made.

Finally, if the new endocrine disruption criteria come into force during the Renewal process we will take them into consideration; this may require a suspension of the evaluation.

Questions

Do Member States agree that:

Those uses already assessed as unsafe should remain considered as such and do not need to be reassessed ?

Those uses currently assessed as ‘safe’ should be reevaluated ?

If the new endocrine disruption criteria become available then creosote should be assessed against them ? This is likely to require a suspension in the evaluation.

26 October 2016