Regulatory Update: 37/2008
Issued: 2 December 2008
Annex I inclusions
At the Standing Committee on the Food Chain and Animal Health, 27 & 28 October 2008, a positive opinion was given to include the following active substances in Annex I of Directive 91/414/EEC.
- Aluminium phosphide
- Calcium phosphide
- Cymoxanil
- Dichlorobenzoic acid methylester
- Dodemorph
- Magnesium phosphide
- Metamitron
- Sulcotrione
- Tebuconazole
- Triadimenol
If you are a UK approval holder for an existing product(s) containing any of the above active substances you will be affected by this decision and the following information is relevant to you.
The decision triggers the start of the product re-registration process and you should take action if you wish to ensure continued approval for your product(s). You should consult the post-inclusion deadline and re-registration page on our website. The page sets out information about your obligations and the deadlines that you must meet to maintain your existing product approvals following Annex I inclusion.
Failure to take appropriate action will result in revocation of your relevant national approvals if they contain an active substance listed above.
Note: This is also relevant for approval holders for parallel imported products and off-label approvals. The post inclusion deadline and re-registration page on our website also sets out information about your obligations with respect to maintaining your existing product approvals following Annex I inclusion.
Annex I inclusions – fourth list green route substances
At the Standing Committee on the Food Chain and Animal Health, 27 & 28 October 2008, a positive opinion was given to include the following fourth list active substances in Annex I of Directive 91/414/EEC.
acetic acid, aluminium ammonium sulphate, aluminium silicate, ammonium acetate, blood meal, calcium carbide, calcium carbonate, carbon dioxide, denathonium benzoate, ethylene, extract from tea tree, fat distillation residues, fatty acids C7 to C20, garlic extract, gibberellic acid, gibberellins, hydrolised proteins, iron sulphate, kieselguhr, limestone, methyl nonyl ketone, pepper, plant oils/citronella oil, plant oils/clove oil, plant oils/rape seed oil, plant oils/spear mint oil, potassium hydrogen carbonate, putrescin (1,4-diaminobutane), pyrethrins, quartz sand, repellents by smell of animal or plant origin / fish oil, repellents by smell of animal or plant origin / sheep fat, repellents by smell of animal or plant origin / tall oil crude, repellents by smell of animal or plant origin / tall oil pitch, sea-algae extract (formerly sea algae extract and sea weeds), sodium aluminium silicate, sodium hypochlorite, straight chain lepidopteran pheromones, trimethylamine hydrochloride, urea, Z- 13- hexadecen-11-yn-1-yl acetate, Z,Z,Z,Z-7,13,16,19-docosatetraen-1-yl isobutyrate
In accordance with Regulation 1095/2007 (see Reg Update 34/2007), these active substances were identified as having ‘no harmful effects’ (green route substances) and were included on Annex I accordingly. After Annex I listing, the European Food Safety Authority (EFSA) will conduct a peer review to confirm the ‘end points’ which Member States (MS) will use when re-registering products.
If you are a UK approval holder for an existing product(s) containing any of the above active substances you will be affected by this decision and the following information is relevant to you.
The decision triggers the start of the product re-registration process and you should take action if you wish to ensure continued approval for your product(s). You should consult the post-inclusion deadline and re-registration page on our website. The page sets out information about your obligations and the deadlines that you must meet to maintain your existing product approvals following Annex I inclusion.
Please note the longer deadlines for re-registration for these green route active substances.
Failure to take appropriate action will result in revocation of your relevant national approvals if they contain an active substance listed above.
Note: This is also relevant for approval holders for parallel imported products and off-label approvals. The post inclusion deadline and re-registration page on our website also sets out information about your obligations with respect to maintaining your existing product approvals following Annex I inclusion.
Amidosulfuron & nicosulfuron inclusion – and other corrections
When amidosulfuron and nicosulfuron were included on Annex I, the key dates specified in Directive 2008/40/EC were incorrect. These dates have now been corrected via amending Decision dated 10 October 2008.
As noted in Regulatory Update 33/2008, several deadlines were amended via SANCO/2821/2008 rev 1 amending re-registration deadlines for many active substances. This amending Directive has been added to the table of recent deadlines.
Please note that where amending decisions are taken, we will include a link to these amending documents in our table of recent deadlines.
Other updates
Since previous Regulatory updates were issued, various documents were made available so we have updated the ‘table of recent deadlines’ to reflect this. Data lists are now available for epoxiconazole and metazachlor.
Each time we alert you to new inclusions, and the resultant re-registration requirements, we will update the links to the documentation in this table. You should check this table on a regular basis to determine if e.g. lists of protected studies are now available.
We expect to update this information shortly after the next meeting of the Standing Committee on the Food Chain and Animal Health, to be held in Brussels on 1 & 2 December 2008.
Contact
If you have any queries contact Tracy Roberts, Pesticides Safety Directorate, Mallard House, Kings Pool, 3 Peasholme Green, York, YO1 7PX. Telephone: 01904 455818 or email applicant-enquiries@hse.gsi.gov.uk
