Regulatory Update: 24/2011
Issued: 21 June 2011
Action Required
This regulatory update requires Approval Holders of all products approved for sale/use in the UK during 2010 to provide the Chemicals Regulation Directorate of the Health and Safety Executive with details of all human health related reports or enquiries & Resistance Reporting involving their products, which were received from users or any other source, during last year.
You should make sure you tell us about emails and letters you have received, not just telephone calls.
Please submit your returns only using this spreadsheet. You will need to address an email to hheis@hse.gsi.gov.uk and attach the filled in and saved spreadsheet to it.
You must include details of all enquiries involving human health issues whether or not these involve actual incidents or notified symptoms of ill-health.
Read the front section of the spreadsheet which explains how to fill it in. This is important for both you and CRD as you will better understand the spreadsheet and what we expect from you.
Resistance Reporting
Under Article 56(4) of Regulation 1107/2009/EC approval holders are required to: “report annually to the competent authorities of the Member States which authorised his plant protection product if he has any information available relating to the lack of expected efficacy, the development of resistance and to any unexpected effect on plants, plant products or the environment”
We have included a reminder of this new requirement alongside our annual Human Health Enquiry Incident Survey HHEIS and would be happy to accept any such information alongside your HHEIS return. There is no template for this return and you should simply provide a word document setting out information on the development of any resistance or other unexpected effects for any of your products (identified by MAPP Number if at all possible).Please note, do not include resistance information on the HHEIS spreadsheet.
If we have accidentally sent this to the wrong person, please send an email to hheis@hse.gsi.gov.uk giving us new details so we can make the necessary changes to our contact list. We would also be interested in any information about changes in contact personnel which may happen during the year – it is very important we can contact quickly the person most likely to be able to respond to our request. And it also helps you by making sure we approach the right person in your organisation, allowing you to make a response and not miss the deadline for reply.
Please respond no later than 31 August 2011.
We must emphasise that it is your responsibility as the Approval Holder to make sure we receive a return, even if you employ another business or company to deal with it. You should monitor whether a return is made on your behalf as it will be your company name we place on the website following the survey if we do not receive a reply.
We intend to publish a list of companies who fail to respond. If you (or the business or company you ask to do the work) do not reply to our request, your company will be added to list and made available to the public through our website at the end of the survey.
Background
Approval Holders are under an on-going obligation to submit immediately any new information on the potentially dangerous effects of a product or of residues of an active substance contained in a product, on human or animal health, ground water or the environment.
In addition to this, we conduct a yearly survey of Approval Holders asking for details of all contacts about potential human health effects of your products, no matter how trivial these may seem. This includes enquiries of a general nature, even those where there is no evidence that the pesticide may have caused any ill health effects.
So please tell us the details of all human health related information for all products approved for sale/use in the UK during 2010.
Please note we are asking for human health enquiries and incidents. We do not need reports of any domestic animal, pet or wildlife incident or enquiry made to you.
We will publish a report of the results of this survey. We may make any information that you provide (apart from the personal details of individuals) publicly available.
Information on previous surveys
We have asked Approval Holders to submit reports of all incidents of human ill-health which may be attributable to the use of pesticides for the last eight years. You can find the outcome of these surveys on our website.
