REACH Regulation and its impact on fertilizers in the European Union

We are at a point when European regulation of chemicals, including fertilizers, is of great relevance for sustainability and environmental safety. In this context, Regulation (EC) 1907/2006 (REACH) and Regulation (EU) 2019/1009 have established a set of standards that are key to regulate the marketing and use of EU fertilizers, seeking harmonization for all Member States of the European Union, and having as main objective the protection of human health and the environment.

The following is a summary of the most important aspects of these regulations and their impact on fertilizers.

• Regulation (EC) 1907/2006 (REACH): Establishes the registration, evaluation, authorization and restriction of chemical substances and mixtures. It was established to ensure a high level of protection of human health and the environment from the risks associated with chemicals.
• Regulation (UE) 2019/1009, also known as Fertilizing Products Regulation (FPR): It establishes the provisions for the marketing of fertilizers bearing the CE marking and repeals the former Regulation (EC) 2003/2003. This regulation, applicable from 16th July 2022, does not replace national legislation, allowing fertilizers to be marketed under both regulations.

REACH Regulation: Regulation (EC) 1907/2006.

The REACH Regulation (Registration, Evaluation, Authorization and Restriction of Chemicals) affects all substances manufactured or imported in quantities greater than 1 tonne per year within the European Union. In terms of fertilizers, this means that any manufacturer or importer must register all substances they use, subject to certain exemptions, to ensure that they do not pose unacceptable risks. The exemptions are those products manufactured or imported in quantities < 1T/year or those listed in Annex IV, Annex V and compounds posing low risk to human health such as polymers.

The registration process includes a detailed evaluation of the hazards of each substance and the uses allowed, as well as the implementation of risk control measures. In addition, for substances manufactured or imported in excess of 10 tonnes per year, the submission of a Chemical Safety Report (CSR) is required, which must include a specific assessment of its use as a fertilizer.

The standard information requirements for REACH registration:

Fertilizer Products Regulation (FPR): Regulation (UE) 2019/1009.

Regulation (EU) 2019/1009 establishes the requirements for a fertilizer to bear the CE marking, a mark that ensures its free movement within the European single market. It updates previous regulations and incorporates new requirements such as REACH +.  This is based on the REACH regulation, but incorporates a set of additional, more demanding and strict requirements, the most significant of which are the reduction of the substances that are exempt and the reduction of the minimum quantities for registering a substance.

Unlike REACH, under REACH+ all substances manufactured or imported into Europe, regardless of tonnage, that are used in an EU fertilizer must be registered, by forcing up the range of registration of some substances to a minimum of 10-100T/year and registering these substances for uses other than as fertilizers, having to submit a chemical safety report (CSR) assessing this use.

Under REACH+ exemptions are more limited. Only substances in Annex IV and some sections in Annex V (6, 7, 8, 9 and 10 only for magnesite) of REACH are exempted. In addition, REACH+ requires chemicals used in fertilizers to comply with Annex VI, VII and VIII of the original REACH Regulation, which adds further documentary requirements.

On the other hand, only substances that comply with Annex II regulations are allowed to be used, classifying these substances to be registered by REACH in Component Material Categories (CMC):

• Substances from virgin materials (CMC 1)
• Compost additives (CMC 3)
• Digestate additives (CMC 4 and 5)
• By-products from the food industry (CMC 6)
• Polymers (CMC 8)
• By-products (CMC 11)
• Precipitated phosphate salts and derivatives (CMC 12)
• Thermal oxidation materials and their derivatives (CMC 13)
• Pyrolysis and gasification materials (CMC 14)
• High-purity recovered materials (CMC 15)

Specific information requirements according to the FPR:

We raise several potential cases that can occur for substances included in an EU fertilizer:

• It is not registered under REACH because it is manufactured/imported at < 1T/year? The substance must be registered at 10T/year and prepare a CSR including an assessment of the fertilizer use.
• Is it registered under REACH at 1-10T/year? The registration range should be updated to > 10T/year and prepare a CSR including an assessment of the fertilizer use.
• Is it registered by REACH at > 10T/year? Check that a CSR is available including assessment of use as a fertilizer.

Therefore, if a substance is not registered or updated for the use or for the minimum tonnage range, the manufacturer will have to change supplier, replace the substance or update the tonnage range, and prepare and submit to ECHA a Chemical Safety Report (CSR) including the assessment of the use as a fertilizer.

This is posing a major challenge for fertilizer manufacturers, as classifying products under the new R(EU) 2019/1009 requires full information from suppliers, which is proving difficult. Many of them do not comply with REACH+ requirements due to lack of knowledge or because the investment required to do so is higher than the profits they could make, not being profitable especially if substances are used in small quantities, such as additives.

This implies a limitation of innovation, depending on manufacturers of substances that do not want to comply with REACH+ or a restraint at the regulatory level of the new regulation, having to resort to other marketing channels (e.g. national legislation or mutual recognition).

Conclusion

To ensure compliance with REACH and REACH+, it is essential that everyone in the supply chain, from manufacturers to distributors, is aware of and complies with their registration and chemical safety obligations. At Herogra Group, we are committed to strict compliance with these regulations, ensuring that all our fertilizers meet the requirements set out by the European legislation.

If in doubt, Herogra Group Regulatory team is available to clarify any queries and ensure that all our fertilizers comply with current regulations.