Fertilisers and Pesticides

Safe and effective fertilisers on the EU market

Regulation (EC) No 2003/2003 relating to fertilisers brings into one piece of legislation all the European Union rules that apply to fertilisers — chemical compounds that provide nutrients to plants.
It ensures that these highly technical requirements are implemented uniformly throughout the EU.Regulation (EU) 2019/1009 repeals Regulation (EC) No 2003/2003 as of 16 July 2022.It applies as of 16 July 2022.

KEY POINTS

The regulation only applies to mineral fertilisers consisting of one or more plant nutrients. Other fertilisers are governed by EU countries’ national legislation.
In its Annex I, the regulation lists fertiliser types according to their specific characteristics. Once a fertiliser meets this type designation it may bear the letters ‘EC’. The fertiliser may then be sold and used throughout the EU. This EC designation guarantees farmers that the fertilisers contain a minimum nutrient content and are safe to use.

For a new type designation to be listed in the Annex I to the regulation, the manufacturer of a fertiliser corresponding to that type designation must lodge a request with a national competent authority. This request is forwarded to the European Commission, which consults the other EU countries and decides to accept or reject the application based on the advice of a committee set up by the regulation.

To achieve the EC status, a fertiliser must provide nutrients effectively, not harm human, animal or plant health or the environment and demonstrate it has been subject to the relevant sampling, analysis and test methods.

Manufacturers must keep records that make it possible to trace a fertiliser while it is on the market and for a further 2 years thereafter.
Certain basic information, such as the manufacturer’s contact details and the fertiliser’s main properties, must appear on packages, labelling and accompanying documents.
Specific rules apply to primary* and secondary* inorganic nutrient fertilisers, to inorganic* micro-nutrient* fertilisers and to ammonium nitrate fertilisers of high nitrogen content.

Certain product types have been added for liming materials (materials that neutralise acid soils) and agronomic fertiliser additives, as well as inhibitors (such as nitrogen inhibitors — materials that slow down or prevent nitrification).
It has applied since 11 December 2003 with the exception of Articles 8 and 26(3) which relate to traceability aspects and which have applied since 11 June 2005.

BACKGROUND

In March 2016, the Commission adopted a proposal which aims to simplify the existing legislation, to improve the way the EU’s fertiliser market works and to extend the rules to non-harmonised products, i.e. those fertilisers governed by EU countries’ national laws. To prepare for this initiative, the Commission has conducted various studies into areas such as fertiliser ingredients and the science of plant bio-stimulants.

DOCUMENTS

Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers (OJ L 304, 21.11.2003, pp. 1-194)

Safe and effective fertilisers on the EU market

Regulation (EU) 2019/1009 — laying down rules on the making available on the market of EU fertilising products

It opens the single market for fertilising products which are not currently covered by harmonisation rules, such as organic* and organo-mineral* fertilisers, soil improvers*, inhibitors*, plant biostimulants*, growing media* or blends*.
It lays down common rules on safety, quality and labelling requirements for fertilising products.
It introduces limits for toxic contaminants for the first time. This will guarantee a high level of soil protection and reduce health and environmental risks while allowing producers to adapt their manufacturing process to comply with the new limits.
It maintains optional harmonisation, as it does not prevent non-harmonised fertilising products from being made available on the internal market in accordance with national law and the general free-movement rules.

Scope

The regulation covers 7 categories of fertilising products, namely:

fertilisers:
inorganic fertilisers,
organo-mineral fertilisers,
organic fertilisers,
soil improvers,
liming materials,
growing media,
inhibitors,
plant biostimulants, and
fertilising product blends.

It will replace Regulation (EC) No 2003/2003 which does not include fertilisers produced from recovered or organic materials.

It does not apply to:

animal by-products or derived products which are subject to the requirements of Regulation (EC) No 1069/2009 when made available on the market;
plant protection products covered by the scope of Regulation (EC) No 1107/2009 (see summary).
The rules apply to the design, manufacture and placing on the market of EU fertilising products. The regulation does not apply to the use or the mode of application of the EU fertilising products.

Requirements

The regulation sets out rules for EU fertilising products carrying the CE marking including requirements for:
maximum levels of contaminants and pathogens (disease-causing microorganisms);
minimum content of nutrients and other relevant characteristics depending on the category of the product;
labelling.

Testing the conformity of EU fertilising products must be performed in a reliable and reproducible manner.

Free movement

EU countries cannot restrict the free movement of EU fertilising products for reasons relating to composition, labelling or other aspects covered by this regulation if those products comply with this Regulation’s rules.
EU countries can maintain or adopt rules relating to human health and the environment (which comply with the EU treaties) which concern the use of EU fertilising products, as long as they do not require EU compliant products to be modified or influence the conditions for making them available on the market.

DOCUMENTS

Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (OJ L 170, 25.6.2019, pp. 1-114)

Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers (OJ L 304, 21.11.2003, pp. 1-194)

Pesticide safety on the EU market

Regulation (EC) No 1107/2009 – the placing of plant protection products on the EU market.

The EU attaches great importance to protecting human and animal health and the environment. Standardising rules on the sale of plant protection products helps to achieve this, ensures the smooth working of the single market and improves agricultural production.

It lays down rules for authorising the sale, use and control of plant protection products in the EU. It recognises the precautionary principle which EU countries may apply if there is scientific uncertainty about the risks a plant protection product might pose to human or animal health or the environment.

KEY POINTS

— The legislation applies to products used to protect or preserve plants, influence their growth or destroy and stunt undesired plants.
— To secure approval, an active substance (any chemical, plant extract or micro-organism that acts against pests or on plants) must not have any harmful effects on human health, including vulnerable groups, or any unacceptable effect on the environment.
— Plant protection products must be effective, have no immediate or delayed harmful effect on human health, no unacceptable effects on plants or the environment and not cause unnecessary suffering or pain to vertebrates.
—The competent national authority in each EU country may attach criteria and restrictions such as minimum degree of purity, type of preparation and manner and conditions of use, when approving a pesticide*.
—The authority gives its first approval for a period not exceeding 10 years. Approval of a renewal request may be for no more than 15 years.
— Applications for approval of an active substance, accompanied by the necessary scientific information, must be submitted to national authorities. They have a maximum of 12 months to examine the request.
— Holders of an authorisation in one EU country may use the mutual recognition procedure to request its use in another.

ACTS

Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309 of 24.11.2009, pp. 1–50)

The successive amendments to Regulation (EC) No 1107/2009 have been incorporated into the original text. This consolidated version is of documentary value only.

Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Official Journal L 93 of 3.4.2013, pp. 1–84). See consolidated version.

Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Official Journal L 93 of 3.4.2013, pp. 85–152). See consolidated version.

Pesticides in the EU — ensuring their sustainable use

Directive 2009/128/EC — EU action to achieve the sustainable use of pesticides

It sets rules for the sustainable use of pesticides by reducing their risks to human health and the environment.
It promotes the use of integrated pest management and different techniques such as non-chemical alternatives.

KEY POINTS

EU countries must:
adopt national plans setting objectives, targets, measures and timetables to reduce health and environmental risks from pesticide use;
ensure all professional users, distributors and advisors receive proper training;
inform the general public and promote awareness-raising programmes about the potential risks from pesticides;
require pesticide application equipment to undergo regular inspections (at least once by 2016, then every 5 years up to 2020 and every 3 years thereafter);
ban aerial spraying;
protect water, especially drinking water, from the impact of pesticides;
ensure that the use of pesticides is reduced or banned in certain areas such as public parks, playgrounds, sports fields or near healthcare facilities;
require professional users to follow safety precautions when handling and storing pesticides and treating their packaging and remnants;
take all necessary measures to promote low pesticide pest management.

The legislation does not prevent EU countries from restricting or banning the use of pesticides in specific circumstances or areas.
By 14 December 2012, EU countries were to communicate their national plans to the European Commission and to other EU countries.
By 14 December 2014, the Commission was to submit a report on the national plans to the European Parliament and the Council.
By 14 December 2018, the Commission must submit a report to the European Parliament and the Council on the progress EU countries have made in implementing their national targets.
It entered into force on 25 November 2009. EU countries had to incorporate it in national law by 14 December 2011.

ACTS

Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides (OJ L 309, 24.11.2009, pp. 71-86)

Successive amendments to Directive 2009/128/EC have been incorporated into the basic text. This consolidated version is for reference only.

Safe insect repellents, disinfectants and other industrial chemicals (biocides) in the EU

Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products.

Biocidal products (household disinfectants, insecticides and other chemicals) are used to suppress pests (parasites, fungi, bacteria, etc.) or to protect materials. However, as their properties can pose risks to humans, animals and the environment, they are regulated at European Union level.

It harmonises the EU’s rules concerning the sale and use of biocidal products, while ensuring high levels of protection of human and animal health and of the environment.

Approval

In order to be allowed to be sold in the EU, all biocidal products require a permit. The active ingredients that they contain must also be approved.

The evaluation of biocides’ active substances is carried out at EU level. For each active substance that needs to be evaluated, an EU country is appointed ‘rapporteur’ . It is responsible for producing an evaluation report which is then discussed by all the EU countries with a view to reaching a decision at EU level to approve (or not) the substance.

Active substances that meet the exclusion criteria are not approved. These are substances that are carcinogenic, mutagenic or toxic to reproduction, endocrine disruptors, persistent*, bioaccumulative* and toxic* (PBT) or very persistent and very bioaccumulative (vPvB). Exemptions are possible, however, if the risks are negligible.

The risks associated with nanomaterial biocides* must be specifically assessed.

The approval of an active substance is granted for a period not exceeding 10 years.

Approved active substances are listed on the European Chemicals Agency (ECHA) website.

Authorisation

Once an active substance is approved, companies must apply for permission to place their products on the market in one of the following ways.

— By submitting a request for EU authorisation with the ECHA: if the product is deemed safe, it can be sold directly throughout the EU without the need to obtain specific national authorisation.
— By submitting a request for national authorisation if the product is to be sold in a single country. If permission is granted, companies can put the product on the market of other EU countries based on the principle of mutual recognition of the authorisation of the product.
There is also a simplified authorisation procedure for the least harmful products that meet certain criteria, such as those that do not contain substances of concern or nanomaterials.

Data sharing

To minimise costs and the use of animal testing, the regulation requires the sharing of data on approved substances and products authorised in the EU. The agency has therefore set up an information system (Register for Biocidal Products).

Treated objects

The regulation covers articles that have been treated with or containing a biocidal product (such as furniture and food packaging). Items can only be treated with active substances that have been approved in the EU and must be labelled as such.

REFERENCES

Regulation (EU) No 528/2012

Regulation (EU) No 736/2013

Regulation (EU) No 837/2013

Regulation (EU) No 334/2014

Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, pp. 4-13)

Commission Implementing Regulation (EU) No 88/2014 of 31 January 2014 specifying a procedure for the amendment of Annex I to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (OJ L 32, 1.2.2014, pp. 3-5)