The legal framework for regulating chemicals in the EU is Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). REACH came into force on 1 June 2007.
REACH requires registration of chemical substances that are manufactured or imported into the EU in quantities of 1 Tonnes per Annum (TPA) or more, unless the substance is exempted from the scope of registration. This applies to substances on their own, in mixtures, or in articles when the chemicals are intended to be released under normal or reasonably foreseeable conditions of use of the article. Registered substances can in principle circulate freely on the internal market.
EU Regulation1107/2009 established the plant protection industry. Plant protection products (PPPs) in the European Union under Regulation (EC) No 1107/2009 Data requirements have increased, and risk assessment schemes have become more complex. The European Food Safety Authority (EFSA) is constantly developing new guidance documents.
Plant protection products (PPPs) are placed on the market in the European Union under Regulation (EC) No 1107/2009. Pesticides are products that are delivered to the consumer in the form of active chemicals, safeners, or synergists, and are designed for one of the following purposes:
unless the main objective of these goods is deemed to be for reasons of hygiene rather than for the protection of plants or plant products (e.g., fungicides, insecticides), protecting plants or plant products against all hazardous organisms or stopping the action of such organisms.
other than as a nutrient, impacting plant life processes, such as plant growth regulators and rooting hormones.
preserving plant goods, to the extent that such substances or products are not subject to special Community preservative rules (for example, extending the life of cut flowers).
destroying unwanted plants or parts of plants, except algae, unless the products are applied to soil or water to protect plants (e.g., herbicides/weedkillers to kill actively growing weeds); checking or preventing undesired plant growth, except algae, unless the products are applied to soil or water to protect plants (e.g., herbicides/weedkillers to prevent weed growth).
The data requirements are set out in Regulation (EU) No. 283/2013 for the active substance and in Regulation (EU) No. 284/2013 for the product formulation along with national requirements which are specific to each Member State. However, writing EU regulatory dossiers is one of the most important tasks. Data must be provided in a draft Registration Report dRR. The report consists of core assessment for zone and national addenda as per Member State (MS) requirement. Below are required procedures:
Compilation and preparation of dossier
Authority comment’s reply with scientific justification
Communication with authorities
Task Force identification and management
Management of the entire authorization process
The current data requirements for the EU dossier of an active substance are set out in. Regulation (EU) 283/2013. These data facilitate an in-depth assessment of the active substance. The data are sub divided into various sections:
Physical and chemical properties
Information regarding use
Methods of analysis
Toxicology and metabolism
Residues in food and feed
Fate and behavior in the environment and
CLP regulation came into force on 20 January 2009. It gives harmonized requirements for the classification, packaging and labelling of the articles and chemical substances. CLP regulation is based on the United Nations’ Globally Harmonized System (GHS) and purpose to ensure high level of protection environment and human health.
1. The CLP regulation requires manufacturers, importers, and other downstream users to do correct classification, labelling and packaging of the substances according to the guidelines before they reach the market.
2. After the classification of substance, it must communicate to the supply chain with its hazard’s information.
3. The labelling of hazard is done to classify the level with labels and SDS which must be communicated to the supply chain till the consumers along with the management and precautionary statements associated with the risks.
Plant protection products (PPPs) contain both traditional synthetic pesticides and biopesticides. According to Regulation (EU) No 1107/2009, placing PPPs on the EU market requires two procedures. To begin, the active chemical is reviewed and approved at the EU level, and it will be included to a list of approved compounds that will be renewed periodically. Second, the formed product is examined and authorized at the level of the Member State (MS), which is only possible if the active component has already been approved at the EU level.
To get approval of an active substance at the EU level,
An applicant must select a Member State (MS) that will act as the Rapporteur Member State (RMS) for the active substance.
When the chosen MS agrees to do the evaluation, the applicant will send a Draft Assessment Report (DAR) to the RMS.
The RMS performs a formality check within 1.5 months before starting the scientific evaluation.
When the RMS considers the DAR as complete, the scientific evaluation of the dossier can start. The RMS has 12 months to do the scientific evaluation but can issue clock-stops for a maximum of 6 months in total in case additional information is needed from the applicant.
Once the RMS has evaluated the active substance, the RMS will submit the DAR to EFSA. EFSA will circulate the DAR to the applicant and the other MS. The other MSs have a maximum of 2 months to comment on the DAR.
The DAR within 5 months and can issue clock-stops of maximum 3 months to the applicant.
The RMS has a maximum of 2 months to evaluate the additional information requested by EFSA.
EFSA will issue a scientific opinion based on the assessment of the RMS, which will be sent to the European Commission (EC). The EC has 6 months to do the risk management and issue a final review report to the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF), where a final decision on whether to approve the active substance will be taken.
The total process of getting approval for an active substance should take between 2 and 3.5 years according to the regulation. In practice, these timelines are often much longer.
The first approval of an active substance is typically valid for 10 years.
The data requirements for active substances are listed in Regulation (EU) No 283/2013. Chemical active substances should comply with the data requirements in Part A of this regulation and microbial active substances should comply with the data requirements in Part B of this regulation. The data on the active substance should cover:
Identity of the active substance.
Physical and chemical properties of the active substance (or biological properties of the micro-organism).
Further information on the active substance.
Toxicological and metabolism studies.
Residues in or on treated products, food, and feed.
Fate and behavior in the environment.
Although "biopesticides" are not a legal category, the pesticide categories "basic compounds" and "low risk substances," as described in Regulation 2017/1432, amended Regulation 1107/2009, were introduced in August 2017. Because biological chemicals, despite their natural origins, are not always innocuous, the EU uses a risk-based authorization method. While a shortened dossier may be filed for low-risk medications, significant efficacy must still be demonstrated. Biopesticides should generally be classified as low-risk active chemicals, allowing for a faster introduction of biopesticide candidates that fit these criteria.
Regulation 1107/2009 currently approves 18 basic drugs and ten low-risk substances. Basic chemicals are substances that are not intended as crop protection products but may have crop protection capabilities, and their approval is based on previous tests conducted in compliance with other EU legislations. For an indeterminate period, authorization is granted for the entire EU.
Low-risk chemicals must meet the standards outlined in Regulation 1107/2009's Annex II. Low-risk chemicals, unlike traditional pesticide active ingredients, may be approved in part based on literature evidence and scientifically reasoned conclusions.
Low-risk criteria are used to microbial insecticides, baculoviruses, and semio-chemicals (e.g. pheromones). Low-risk active ingredients (whether biological or synthetic) are assessed (evaluated) in 120 days, compared to 12 months for conventional active ingredients, and low-risk active chemicals are approved for 15 years, rather than the standard 10 years. Furthermore, authorization fees are reduced, which encourages smaller businesses to introduce low-risk goods (such as biopesticides).
All the substances used in making plant protection products have been audited regularly by the audit team of both the member state and the Commission. Rules and Regulations are dynamic and keep on evolving with rapid growth in scientific and technological advancements. Therefore, the European Commission keeps updating its website to update the member state, the producers, and scientific communities to abreast with the rapid developments.
The Authority has the leeway to audit and asks for more supplementary information under article 6(f) to the producers. They are also supposed to be complying with all the developments that are happening. Article (4) made sure that they have a legal liability to improve and innovate the product consistently.
All the stakeholders, especially the producers, are asked to keep all the data for the last five years to keep track of the whole process. In addition, producers should regularly update the authorities about the efficacy and benefits of the product attached with the entire set of data on an annual basis.
As and when producers applied for the renewal, they are asked to produce new data to supplement.
Suppose producers failed to comply with the mandated process. Sometimes, they can get some flexibility, but at the same time, if things went wrong or tried to do away with the process. There can be severe repercussions for the PPP in the form of civil and criminal charges.