List of Candidates for Substitution - Q&A
The UK has left the EU, new rules from January 2021
The transition period after Brexit comes to an end this year.
Q1. What is the ‘list of candidates for substitution’?
On the 27th January 2015, the European Commission published its list of candidates for substitution. Full details are available on the Commission website.
Candidates for substitution are active substances approved for use in plant protection products (PPPs) meeting one or more of the conditions listed in Annex II point 4 of Regulation 1107/2009. They have all been evaluated and are approved for use in the EU in authorised PPPs.
Q2. What is the purpose of the list?
Substances on the list satisfy the standard for approval, but have one or more characteristics which are less favourable than most other active substances. Uses of PPPs which contain these substances are subject to comparative assessment and substitution.
Q3. What is comparative assessment?
Comparative assessment provides a means for determining the advantages and disadvantages of a PPP containing a candidate for substitution as compared to products containing other active substances.
Q4. When will comparative assessments be carried out?
Member States must conduct a comparative assessment when evaluating an application for authorisation, or renewal or amendment of an authorisation of a PPP containing a candidate for substitution.
Only applications which require evaluation of data will trigger a comparative assessment; applications for purely administrative changes to authorisations will not.
Q5. What is ‘substitution’?
‘Substitution’ of PPPs means that an authorisation of a particular use is refused or restricted if the comparative assessment shows that an alternative product or a non-chemical control or prevention method presents a ‘significantly lower risk’ and no significant practical or economic difficulties would arise from the substitution.
Q6. Is this a black list of dangerous substances?
No. This is not a black list. Candidates for substitution meet the EU’s high regulatory standards for approval and have been identified as having one or more properties which is/are less favourable then the majority of approved substances.
Q7. Should the substances on the list be removed from the market?
No. The regulatory requirements governing PPPs offer a high standard of protection. Substances are only approved for use in PPPs when they have demonstrated no harmful effects on human or animal health or any unacceptable effects on the environment. Candidates for substitution have met these high regulatory standards.
Q8. What do I do if a Plant Protection Product in my store/garden centre/shed contains a ‘candidate for substitution’?
Nothing. Inclusion in the list simply requires HSE to carry out a comparative assessment in line with Article 50 of the Regulation of each application for authorisation of a PPP containing a candidate for substitution.
Q9. When will comparative assessment apply? How will HSE undertake comparative assessment and substitution?
Comparative assessment is required for relevant applications submitted on or after 1 August 2015.
Guidance and information on comparative assessment was issued in Regulatory Update 23/2014 and Comparative Assessment And Substitution: Guide for UK applicants for Plant Protection Product authorisation.
Q10. Why is glyphosate not on the list?
Glyphosate did not meet the criteria outlined in point 4 of Annex II of the EC Regulation 1107/2009.