A Complete Guide to EU Technical Equivalence (TE) Assessment for Pesticide Active Substances

Overview: EU Active Substance Technical Equivalence (TE) Assessment

In recent years, more and more pesticide companies have begun to focus on the EU market for product registration and expansion. Compared to active substance approval and formulation registration, the EU Active Substance Technical Equivalence (TE) assessment is a quicker pathway to enter the EU market.

The EU TE assessment is governed by the EU Plant Protection Products (PPP) Regulation (REGULATION (EC) No 1107/2009) and applies to the EU-level approval of active substances (technical materials). For the authorization of EU formulations, aside from using the reference source of the active substances that have already been approved, they can also incorporate a new source of active substances from a different manufacturer. As long as the new source meets the EU active substance technical equivalence requirements—what we refer to as the EU TE assessment—it can enter the EU market. This is the first step and one of the most fundamental and important stages in obtaining authorization for pesticide products in the EU.

Through the TE assessment, the EU can determine the feasibility of data reduction or authorization, avoiding unnecessary repeat testing and assessments, and saving social resources. For businesses, the TE assessment provides an opportunity for data sharing, reduces registration costs, and serves as a quality assurance, boosting corporate image and visibility. The EU TE assessment is characterized by its short review period, low costs, and rapid outcomes, helping businesses quickly enter the EU market, making it the first step in capturing the EU pesticide market.

Since 2016, REACH24H Technology’s agrochemical team has successfully completed EU technical equivalence registrations for over 350 active substances from more than 80 companies, gradually forming a scale effect and accumulating an extensive database of EU TE registration projects, thereby assisting businesses in obtaining entry into the EU market.

Who Can Apply for the EU TE Assessment?

The EU TE assessment has no specific requirements for the applicant’s identity or location. Generally, Chinese companies (whether manufacturing or trading) can directly apply for TE assessments without needing to set up a subsidiary in the EU. However, some EU member states may require the company to provide a local contact and address.

How to Choose the Appropriate TE Assessment Reference Member State (RMS)?

The EU TE assessment is EU-wide, so once technical equivalence is granted in the Reference Member State, other EU Member States will recognize the result. However, the choice of the Reference Member State (RMS) for the assessment should consider several factors, such as the Member State‘s evaluation capacity, staff configuration, workload, review style, evaluation fees, timelines, and responsiveness.

Different RMSs may have slightly different requirements in terms of data, depending on the evaluation officers’ review style and technical capabilities. Some cautious member states may ask for additional data that goes beyond the standard TE criteria. In these cases, companies need experts to argue against unreasonable data requests made by authorities. REACH24H’s agrochemical team, with expertise in areas such as batch production processes and toxicology, has successfully helped companies counter unreasonable data demands from authorities, thus improving the success rate of TE assessments.

Additionally, REACH24H maintains good communication and collaboration with various EU member states, including the Netherlands, Belgium, France, Germany, Ireland, Austria, Spain, Sweden, etc.

EU TE Assessment: Two Stages

The EU TE assessment is carried out in two stages. When comparing a new source of the active substance with the approved reference source, the process is divided into Tier I and Tier II.

• Tier I (First Stage): This stage mainly evaluates the chemical composition, production process, five batches analysis, and technical specifications. If this stage confirms that the new source and reference source are technically equivalent, the TE assessment is approved.
• Tier II (Second Stage): If Tier I does not establish equivalence, the assessment enters the second stage, which is more complex. This stage evaluates the toxicological and ecotoxicological properties and hazards of the substance.

When submitting the application materials for Tier I, the following points should be noted:

• The production date of the five batch samples should preferably be no more than five years old.
• The batch reports should include detailed analysis method validation.
• Pay attention to potential side reactions during production, explaining possible reasons for impurity formation.
• If high-toxicity solvents are used, the residual amount must be closely monitored.
• The spectra in the reports should be clear.
• Ensure that manufacturing techniques and batch reports are consistent.

If the first stage confirms the equivalence between the new and reference sources, the TE assessment will be approved. If new impurities or an increase in existing impurities exceed EU limits, the assessment will proceed to Tier II.

After approval, the RMS will issue an official approval letter as proof of the TE assessment’s success. The assessment report will also be published on the EU’s internal sharing platform (CIRCABC). The approval letter generally includes information such as the applicant’s name, the manufacturer of the active substance, the approved active substance specifications, and the registration application number.

Once the company receives this approval letter, it can provide it to downstream formulation manufacturers. Additionally, companies must provide the Letter of Access (LOA) for the data used in the TE assessment. If the TE-assessing country is not the same as the formulation registration country, other documents such as the TE assessment draft may also be required.

How to Choose the Right Product for EU TE Assessment?

When selecting an active substance for the EU TE assessment, companies should consider multiple factors, including the active substance’s approval status, risk of ban, non-renewal or restriction, market potential, and economic benefits.

The substance must be an active substance already approved at the EU at EU level. If it is a new active substance, it requires submission of a new active substance application. For substances under patent protection, companies can apply for TE, but the product cannot be sold until the patent expires. For substances nearing the end of their patent protection period, companies are advised to plan ahead and act quickly to seize the market opportunity.

In addition, the risk of the substance being banned or restricted is also a key consideration. In recent years, the EU has been phasing out older substances with higher risks, particularly those with carcinogenic, mutagenic, or endocrine-disrupting effects. Companies need to be mindful of these risks when selecting products. If uncertain, REACH24H can provide guidance.

Lastly, the market potential and economic benefit of the product in the EU should also be considered. After TE registration, the market return from selling the product is generally substantial, far exceeding the initial registration costs.

FAQ

• Does the Tier II of the TE assessment take long?
  The Tier II’s duration depends on the time taken by the company to provide supplementary materials and the official review time. If the company already has relevant toxicology reports (e.g., Ames, micronucleus), additional testing may not be necessary.REACH24H ’s experts are highly experienced in QSAR reports and can control preparation time. Typically, the official review time ranges from 1 to 3 months.
• Can data after the first data protection period be used for free? Where can this free data be accessed?
  After the data protection period expires, common toxicology data such as Ames and micronucleus tests can be freely referenced, as long as the assessment does not require advanced data. EU pesticide regulations have detailed rules regarding data protection, and REACH24H can assist in querying data when needed.
• Why do official authorities request additional materials after submitting the same documents to different countries?
  When submitting the same set of application documents to different countries, this situation may arise because different assessment countries may emphasize different aspects of the review.
• What are the requirements for increased impurity levels?
  There are no specific regulations in SANCO/10597/2003-rev.10.1 regarding increased impurity levels. Generally, the impurity levels should not exceed EU limits. If they do, the assessment will move to the second stage Tier II. This may require toxicology experts to evaluate whether the risk is manageable, and if it is, the Tier II may still be approved.

Why Choose REACH24H?

• Profound experience: We are the first consulting agency in China to independently complete EU pesticide registration.
• Outstanding performance: By November 2021, REACH24H had successfully helped domestic and foreign enterprises to complete hundreds of TE applications in the EU, involving more than 90 kinds of products, and had reached a 100% approval rate. We have serviced more than 80% of China’s top 100 pesticide enterprises.
• Strong technical strength: With analytical chemistry, chemical engineering, biology, pharmacology, environment, and other professional backgrounds of senior technical personnel, composed of a strong team, it has a number of internationally certified toxicologists and risk assessment experts.
• International service level: With customer service staff fluent in English, Chinese, Korean, Japanese, Spanish, German, and other languages, we provide efficient and effective service to international clients.
• Rich accumulation: We have accumulated rich experience in dealing with EU pesticide regulations and technical consulting services for many years, and we are very good at solving difficult project problems.
• Superior resources: To cooperate with many excellent laboratories at home and abroad, to design professional and efficient test programs for enterprises, and to provide quality services.
• Good relationship channels: We have established long-term, friendly communication channels with EFSA, HSE, CTGB, and other EU competent authorities and experts, significantly enhancing our service quality and efficiency.