About the EU Fertilising Products Regulation and other rules on fertilising products
Table of contents:
Fertilising products are products used as fertilisers, liming agents, soil improvers, growing media, inhibitors or plant biostimulants. If your fertilising product meets the requirements, you can get it CE marked as an EU fertilising product. This is a voluntary certification, accepted in all EU countries, which shows that your product meets certain criteria for quality, efficiency and safety. In Sweden, there is no requirement for national authorisation or CE marking in order to sell fertilising products.
There are no mandatory rules at EU level, nor in Sweden nationally, requiring fertilising products to be CE marked or have a product authorisation to be placed on the market. Instead, the EU regulation on placing EU fertilising products on the market, (EU) 2019/1009, makes it possible for your company to voluntarily certify your product to gain market access in all EU countries.
The main advantages of CE marking your fertilising product under the EU Fertilising Products Regulation are
- CE marked EU fertilising products can be sold throughout the EU, including in member states where a national product authorisation is otherwise required for fertilising products.
- The CE marking as an EU fertilising product shows your customer that your product fulfills the requirements of the regulation for quality, efficiency and safety .
Important to separate from plant protection products:
- A fertilising product may not be marketed or function as a plant protection product, when used as recommended. If it does, your product needs product authorisation as a plant protection product in accordance with the EU regulation on placing plant protection products on the market, (EC) 1107/2009. This also applies to fertilising products with dual function/product claims, i.e. which are fertilising products and, in addition, are also covered by the scope of the EU plant protection regulation.
Is your product a plant biostimulant, or a plant protection product?
A product that affects plant life processes other than as a nutrient, is in most cases considered a plant protection product and must be authorised as such under the EU Plant Protection Products Regulation, (EC) 1107/2009. However, a plant biostimulant within the definition in Article 3.34 of that regulation does not count as plant protection product, and is exempted from the scope of (EC) 1107/2009.
3.34: 'plant biostimulant' means a product stimulating plant nutrition processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere:
(a) nutrient use efficiency;
(b) tolerance to abiotic stress;
(c) quality traits;
(d) availability of confined nutrients in soil or rhizosphere
EU Fertilising Products Regulation - content and implementation
The regulation divides products into different categories according to their function, such as for instance fertilisers, soil improvers or plant biostimulants. For each of these so-called product function categories , there are specific requirements on content, demonstrated efficacy, limit values for undesirable substances, and other factors.
There are also requirements on what materials the EU fertilising product may consist of, and on recycled materials, which cease to be waste.
The regulation also contains rules on labelling, on the certification procedure, and on market surveillance of EU fertilising products.
- Fertilisers have the function of supplying plant nutrients to the system. They can be organic, organic-mineral or inorganic, and are further divided into several subcategories.
- Liming agents regulate the pH of the soil, improve soil structure and the ability of the soil to deliver nutrients to plants.
- Soil improvers are materials that improve soil quality and properties.
- Growing media are materials other than soil that plants can grow in.
- Inhibitors are materials added to a fertiliser to delay the release of nitrogen into the soil, thus avoiding nitrogen losses.
- Plant biostimulants are materials improving the nutrition processes of crops, in particular by improving how efficiently they use nutrients and their resistance to environmental conditions. They must not have plant-protective properties against harmful organisms, or any such product claims.
- Fertilising product blends are composed of two or more EU fertilising products in product function categories 1-6.
The component materials of your EU fertilising product must comply with the requirements set out in Annex II of the EU Fertilising Products Regulation. Examples of categories of component and input materials that may be included in EU fertilising products are
- raw material substances and raw material mixtures
- plants, plant parts or extracts, compost
- digestate, by-products from the food industry, certain animal by-products
- micro-organisms
- nutrient polymers and other polymers
- precipitated phosphate salts
- materials from thermal oxidation, pyrolysis or gasification
- recycled materials of high purity.
If you want to use a waste material as a component in, or as sole constituent of a fertilising product, you must first ensure that the material has ceased to be waste. It must be clear at what point, and by which procedure the material ceases to be waste and becomes a product. The EU Fertilising Products Regulation is one of the EU regulations under which materials that are waste (as defined in Directive 2008/98/EC) can cease to be waste.
Read more at the Swedish EPA about when waste ceases to be waste (in Swedish) External link.
In Sweden, sewage sludge for agricultural purposes may not be sold or transferred if the sludge contains metals that exceed certain content limits.
Your EU fertilising product must be labelled in accordance both with the rules of the CLP regulation and the specific labelling requirements of the EU Fertilising Products Regulation.
Labelling in Swedish
- CLP Regulation, (EC) 1272/2008, on classification, labelling and packaging of substances and mixtures.
If labelling is required according to CLP, the labelling must be in Swedish. - EU Fertilising Products Regulation. The packaging must be labelled in a language that is clear, and that is easily understood by end users in the country where the product is marketed - for instance Swedish, when the product is marketed in Sweden.
Content of the label according to the EU Fertilising Products Regulation
The packaging of an EU fertilising product must always contain information to identify the product and make it traceable, for example
- information on the CE marking and on the notified certification body that carried out the conformity assessment,
- information identifying the EU fertilising product in the packaging - for example, product name, batch number and date of manufacture,
- the trade name/brand and postal address of the manufacturer/importer and of any party that repackaged the product,
- the product function category to which the product belongs,
- instructions for use and recommended storage conditions,
- safety and environmental protection information.
The specific labelling requirements for the different categories of EU fertilising products can be found in Annex III of the regulation.
Labelling responsibilities in the EU Fertilising Products Regulation
Both manufacturers and importers are responsible for ensuring that EU fertilising products are accompanied by the information required in Annex III. If an EU fertilising product is supplied in a package, the information must be provided in a label on the package. The responsibilities for labelling for manufacturers and for importers are set out in Chapter 2 Article 6 and Article 8, respectively.
An importer or distributor is considered to be a manufacturer and to have the obligations of a manufacturer under Article 6, if the importer or distributor (see further in Article 10 of the regulation):
- places an EU fertilising product on the market under own name or trademark,
and/or
- modifies an EU fertilising product already placed on the market in such a way that compliance with the regulation may be affected.
For full labelling requirements under the EU Fertilising Products Regulation, see Annex III of the regulation and the EU guidance document.
European Commission guidance on the labeling of EU fertilizer products External link.
There is currently no Swedish notified body for the certification of EU fertilizer products. A list of all notified bodies can be found on the European Commission website.
For EU fertilising products, the EU Fertilising Products Regulation applies in parallel to the CLP and REACH regulations, among others. In Sweden, the Swedish Chemicals Agency is the authority responsible for market surveillance acording to the EU Fertilising Products Regulation, as well as for market surveillance according to the REACH and CLP regulations.
Swedish rules for fertilising products
There is no requirement for product authorisation or CE marking for putting fertilising products on the Swedish market. Mutual recognition between Sweden and another member state of a national product authorisation is therefore neither necessary nor possible for fertilising products.
Regardless of whether your fertiliser product is CE marked as an EU fertilising product or not, there are some rules that only apply in Sweden.
Many fertilising products are subject to registration in the Swedish Product Register on the import and manufacture of chemical products and biotechnological organisms.
- On our website you will find a list of which customs tariff codes/product groups that are covered by the obligation to report. Check the list for a code matching the first six digits in the international customs tariff code of your product. You can find the list via this webpage:
Products subject to notification - Swedish Chemicals Agency - Please note that a registration in the Product Register is only a notification made by the company. It does not mean that the product is authorised or approved by us. Therefore, registration in the Product Register cannot be used as a basis for mutual recognition in another Member State, where there are national authorisation requirements for fertilising products.
- If you manufacture or import certain fertilising products into Sweden, you must also report the cadmium content of the products to the Product Register.
Registration of cadmium to the Product Register
If you have questions about how to report, contact our Product Register directly.
You can find contact details for the Product Register here
For certain types of fertilisers on the Swedish market, a limit value of 100 grams of cadmium per tonne of phosphorus applies. This limit applies to all such fertilisers in Sweden and thus also to fertilisers that are CE marked according to the EU Fertilising Products Regulation. This is due to a derogation granted by the EU to Sweden and a few other member states to maintain a stricter cadmium limit than is set down in the EU Fertilising Products Regulation.
Read more here about the Swedish rules on cadmium in fertilisers
Read the cadmium derogation for Sweden at the EU website External link.
Other EU rules on fertilising products
EU regulations covering many different types of fertilising products include
- REACH Regulation (EC) 1907/2006 on the Registration, Evaluation, Authorization and Restriction of Chemicals. REACH also contains requirements for users of chemicals and rules on information.
- CLP Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures.
- EU rules on fertilisers based on animal by-products and on livestock manure.