Application of Technical Equivalence Assessment in EU and UK

In EU and UK, application of technical equivalence (TE) assessment is the easiest way to gain market access for your pesticide technical materials due to its short review periods and low costs. If an active substance has been approved at the EU level and the new source (i.e., your technical product) has the same or less harmful effects due to its impurities compared to the reference source, then the new source can be considered (eco)toxicologically equivalent to the reference source. Once the TE application is approved, you will get an approval letter and then you can sell your technical materials to EU without the need to repeat lots of studies. UK has similar regulatory requirements and similar process.

When Is Application of Technical Equivalence Assessment Required?

Technical equivalence assessment is usually required for technical materials used for  plant protection products and biocidal products under the following circumstances: 

1. When technical material comes from a new/different manufacturer other than the applicant of the reference source.
2. When the production is switched from a pilot scale to a industrial scale commercial production, the latter is regarded as a different source.
3. When there is a change in the method of manufacture (e.g. process or quality of starting materials) and/or a change of the manufacturing location, and/or the addition of one or more alternative manufacturing locations (production sites)

For technical materials used for plant protection products, usually Member States are doing the assessment. For technical materials used for biocidal products, ECHA is responsible for assessing technical equivalence. 

Who Can Apply for Technical Equivalence Assessment?

Usually manufacturers of technical materials in or outside of EU apply for technical equivalence assessment for their products to demonstrate the quality and compliance of their products. Importers of technical materials and downstream formulation manufacturers can also for technical equivalence. 

Tiered Approach for Technical Equivalence Assessment

The assessment is divided into two tiers and the applicant needs to indicate when submitting the application whether the application is for Tier I or for Tier II.

In Tier I asessment, substance identity, chemical composition, analytical profile of five representative batches, description of the analytical method used for the determination of the substance are assessed. In Tier I assement, impurties are main concerns, particulary those significant impurities present in quantities ≥ 1 g/kg and those relevant impurities posing tox or environmental concerns even if present in quantities less than 1g/kg in technical materials. 

If technical equivalence cannot be established based in Tier I, the applicant may request authorities to perform a Tier II assessment based on the hazard profile using toxicological and eco-toxicological data. Laboratory studies, QSAR and TTC can be used as supporting data. 

Our EU Pesticide Regulatory Services

Our experienced team at CIRS Group have obtained dozens of approval letters for technical equivalence assessment. We can help you navigate the complex pesticide regulatory barriers in the EU and bring your pesticide products to the EU market efficiently and compliantly.

Our services include:

• Application of Technical Equivalence (Tier 1 and Tier 2) in EU and UK

• Data Gap Analysis

• GLP Study Monitoring Services

• Dossier Preparation and Submission

• QSAR and TTC

For more information on how we can assist with your pesticide registration needs in EU, contact us today via Email: service@cirs-group.com.