Scientific regulatory affairs
Regulatory support for biostimulants
There are, to date, no specific regulations for soil conditioners, soil improvers and biostimulants in domestic legislation. According to DEFRA, fertilisers can placed on the UK market legally according to three routes:
In case a fertiliser responds to the provisions in EU Regulation (EC) No 2003/2003 it can be sold freely in the UK without further approval or registration process. If a product does not fit within these pieces of legislation (EC Regulation 2003/2003 or UK 1991 Fertiliser Regulation), then they cannot be marketed as a fertiliser.For products not being an EC Fertiliser under EU Regulation (EC) No 2003/2003 : These can be marketed under the domestic regime provided for in the Agriculture Act 1970 , where article 66 (1) describes fertilisers as "used for the cultivation of crops or plants of any description, including trees". For England and Wales, it is S.I. No 2486 that enacts the EC Fertilizer regulation 2003/2003.A fertiliser marketed under the domestic legislative regime must comply with any applicable requirement set out in the Fertilisers Regulations 1991 (GB and 1992 for Northern Ireland). This piece of legislation specifies labeling and packaging requirements. If a fertiliser meets the composition, labelling and packaging standards of this regulation, the fertiliser (or biostimulant product) may be sold in the UK without any formal approval or registration process.Products made from processed animal by-products must comply with the Fertilizer Regulations 1991 and the guidance on Fertilizer from processed ABPs.There are currently no specific requirements in the 1991 Fertiliser legislation for biostimulants. Specific requirements may apply however, if the biostimulant is, for example, mixed with a fertiliser to which these requirements apply or in the event where it would be mixed with a pesticide. In this case, the Plant Protection Legislation would apply. Also, if there are any parts of the product that would shift the product within the definition of a plant protection product (a good example would be a plant growth regulator), it may be subject to Plant Protection Products Regulation (EC) No 1107/2009.In the rather unlikely event that a product would contain more than 28% by weight of ammonium nitrate, the requirements in the Ammonium Nitrate Materials (High Nitrogen Content) Safety Regulation 2003 have to be observed. These products are restricted in Northern Ireland.Mutual recognition will still apply in the UK until Jan 1st 2021. However, there is no established process for DEFRA to approve (or not) a fertilizer through Mutual Recognition. Instead, MRRs in general fall within the remit of the Department for Business, Innovation and Skills, now replaced by the Department for Business, Energy & Industrial Strategy. So, no prior authorisation process is required for fertilisers marketed on the basis of mutual recognition. But then of course, the prerequisite is that the fertilizer product is on the market in another EU Member State.
So, there So, the Mutual Recognition is in place and may be somewhat cumbersome, but there is also the Brexit: On 31th January 2020, the UK left the EU and became a “third country” as regards to the EU. Since then, there is a transition period until 31st December 2020. This time-limited period was agreed as part of the Withdrawal Agreement and will last until at least 31 December 2020. Until then, it will be business as usual for citizens, consumers, businesses, investors, students and researchers in both the EU and the United Kingdom.
The European Commission issued a note to stakeholders on the withdrawal of the UK in the field of fertilizers. The EU rules on EC fertilizers (thus covered under the European Fertiliser Regulation 2003/2003) will no longer apply in the United Kingdom and as of the withdrawal date, “a manufacturer established in the UK will no longer be an economic operator established in the EU. As a consequence, an economic operator established in the EU-27 and placing EC fertilizers comping from the UK on the EU-27 market, until then considered as a distributor, will become an EU importer in relation to such products.”As a result of the UK no longer being part the EU, corrections are required in the EU regulation to convert it into the “UK fertilizer” regulation and to replace the “EC FERTILIZER” with a “UK FERTILIZER” label. The domestic legislation will also be adapted to reflect these changes. No significant impacts are expected, according to the Explanatory Memorandum 2019.
Manufacturers and companies wanting to place their biostimulants on the UK market are responsible to satisfy that all relevant requirements are met.
The UK authorities also issued a note in case the UK leaves the EU without a deal (which is the case). It states that “the current domestic framework allowing fertilizers to be sold in the UK will remain in place, as it is separate from the EU framework” and “over time, the regulatory framework would be reviewed and rationalized.”
There would be some implications for products currently marketed as “EC fertilizers” that are currently sold in the UK. The UK authorities however do not intend to disrupt the market and have agreed on time-limited adjustment period of no more than two years. This would mean that UK or EU manufacturers do not have to change their labels immediately.
Also, the option to use a new “UK fertilizer” label for these fertilizers is possible, in accordance with the EU Regulation as converted to UK law. After the end of this adjustment period, fertilizers placed on the UK market would need to comply with the current domestic regime or with the requirements of the new UK fertilizer regime. All fertilizers currently marketed in the UK could continue to be imported and marketed in the UK provided they meet the necessary requirements. Whether the UK would take over the revised EU Fertilizer Regulation 1009/2019 covering biostimulants and soil improvers is not known but to be expected.
 Explanatory Memorandum to the Fertilisers and Ammonium Nitrate Material (Amendment) (EU EXIT) Regulations 2019. 2019 No.XXXX. DExEU/EM/7-2018.2 https://ec.europa.eu/commission/presscorner/detail/en/QANDA_20_104 European Commission. Directorate General for Internal Market, Industry, Entrepreneurship and SMEs. Notice to Stakeholders. Withdrawal of the United Kingdom and EU rules in the field of fertilisers. 25 September 2018. Rev 1.
1] Manufacturing and marketing fertilisers if there’s no Brexit deal
Controls and restrictions. To protect plant health, DEFRA sets policy and enforces controls and restrictions on the import, movement and keeping of certain plants, plant products, plant pests and other materials such as soil. That means that if a product contains plant material (including plant products and seeds), soil, growing media, plant pest or other plant pathogenic microorganisms, there may be plant health import controls associated with the product.Enforcement. Local authorities are responsible to control and appoint inspectors for this purpose. “The Fertilizers Sampling and Analysis Regulations 1996 – S.I. No. 1342 describe the official methods for enforcement authorities when taking and handling samples and checking the accuracy of the nutrient declarations of fertilisers sold in GB. The Regulations specify the qualifications of those who can take samples and the form of certification of analysis.” Specific enquiries should be addressed to email@example.com.Imports and inspection (fees). Importers must check if a plant, plant product or other object requires phytosanitary certification to be allowed entry into the EU. You must register with Defra before you import any controlled plants, plant products or objects. These certificates confirm that the goods have been inspected in their country of origin and meet EU standards on the absence of pests and diseases. You find more details on how to get UK custom clearance when importing goods from outside the EU here. These inspections at the border come with certain fees. The height of these fees depends on the plant material to be imported. In some cases reduced inspections fees apply. Check this link when you are importing goods from outside Europe: https://www.gov.uk/import-customs-declaration Importers of Fertilizers into the UK have are well advised to seek certification under the Fertilizer Industry Assurance Scheme (FIAS). “FIAS was launched on 9th January 2006 and assures fertiliser security and traceability in the industry supply chain. The UK government encouraged and supported this industry initiative as an alternative to further legislation.” It looks as if it could be rather difficult to make business in the UK as a fertiliser importer if no certification from FIAS has been obtained.A practical detail as regard to imports:Within 3 days of your consignment reaching the UK, you must post the original phytosanitary certificate to APHA.For consignments landing at Heathrow or Gatwick send the certificate to:Animal and Plant Health Agency1st floorBuilding 4Heathrow Boulevard284 Bath RoadWest DraytonMiddlesexUB7 0DQFor consignments landing anywhere else send the certificate to:Animal and Plant Health AgencyFoss House, 1st FloorKings Pool, 1-2 Peasholme GreenYorkYO1 7PX
 AIC - Import of Fertilisers https://www.gov.uk/guidance/plant-health-controls#legislation https://www.gov.uk/guidance/importing-plants-fruit-vegetables-or-plant-material-to-the-uk#register-as-an-importer https://www.gov.uk/guidance/importing-plants-fruit-vegetables-or-plant-material-to-the-uk#get-materials-inspected-at-the-uk-border https://www.aictradeassurance.org.uk/fias/about-fias/ https://www.gov.uk/guidance/importing-plants-fruit-vegetables-or-plant-material-to-the-uk#get-materials-inspected-at-the-uk-border (2015) Evaluation of the Application of the mutual recognition principle in the field of goods. ENTR/172/PP/2012/FC-Lot 4. Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs 2015 https://ec.europa.eu/commission/presscorner/detail/en/QANDA_20_104 European Commission. Directorate General for Internal Market, Industry, Entrepreneurship and SMEs. Notice to Stakeholders. Withdrawal of the United Kingdom and EU rules in the field of fertilisers. 25 September 2018. Rev 1. Manufacturing and marketing fertilisers if there’s no Brexit deal Explanatory Memorandum to the Fertilisers and Ammonium Nitrate Material (Amendment) (EU EXIT) Regulations 2019. 2019 No.XXXX. DExEU/EM/7-2018.2
scientific regulatory affairs | regulatory support for biostimulants
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