Europe Reach Regulation for Various Sectors

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, 

1. An applicant must select a Member State (MS) that will act as the Rapporteur Member State (RMS) for the active substance.  

2. When the chosen MS agrees to do the evaluation, the applicant will send a Draft Assessment Report (DAR) to the RMS.  

3. The RMS performs a formality check within 1.5 months before starting the scientific evaluation.  

4. 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.  

5. 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. 

6. The DAR within 5 months and can issue clock-stops of maximum 3 months to the applicant.  

7. The RMS has a maximum of 2 months to evaluate the additional information requested by EFSA.  

8. 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.  

9. 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.  

10. 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: 

1. Identity of the active substance. 

2. Physical and chemical properties of the active substance (or biological properties of the micro-organism). 

3. Further information on the active substance. 

4. Analytical methods. 

5. Toxicological and metabolism studies. 

6. Residues in or on treated products, food, and feed. 

7. Fate and behavior in the environment. 

8. Ecotoxicological studies.

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.