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:

the EU Regulation (EC) No 2003/2003
Under the UK 1991 Fertiliser Regulation No 2197
for member of the EEA (European Economic Area), by mutual recognition (Regulation (EU) 2019/515).

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.

Interview

The Scientific Regulatory Affairs training - entry level - what it is about - by Evelyne Güsken