Biocidal and Plant Protection Products
Biocidal products are mixtures containing one or more active substances that serve to repel, neutralize, or destroy harmful organisms.
These biocidal active substances can be chemical substances or microorganisms (bacteria, viruses, or fungi).
Insects, fungi, rodents, bivalves, algae, or bacteria and viruses (including pathogens) are classified as harmful organisms if they have unwanted or damaging effects on humans, their activities and the products they use or produce, or on animals and the environment.
Biocides
Classification of biocidal products
Biocidal products are classified into four main groups, according to Annex V of the Biocidal Products Regulation (EU) No. 528/2012:
- Main group 1: disinfectants
- Main group 2: preservatives
- Main group 3: pest control
- Main group 4: other biocidal products
At Medical Devices Sur Consulting, we offer comprehensive consulting on biocidal products, specifically in the following areas
- Registration of biocides through national, European, and simplified procedures.
- Registration of active substances.
- Registration of similar products.
- Registration of biocidal establishments and services.
- Review and preparation of biocidal product labeling.
We provide a free assessment of your biocidal product and a personalized quote.
The European regulation currently governing these products is Regulation 528/2012.
The European Committee of ECHA regularly publishes updates on products they authorize or restrict. We can keep you informed about all the developments the commission publishes to assess how they may affect the marketing of your product.
Having specialized consulting in biocidal products is key to ensuring legal compliance, product safety, and market access.
In conclusion, at Medical Devices Sur Consulting, we provide assessment, advice, and prepare your dossier whether you are a manufacturer or importer of the biocidal product or active substance to enable marketing of your product in Europe.
Contact us and receive a free assessment!
Plant Protection Products
We can define a plant protection product as a product composed of one or more active substances whose main function is to:
a) Kill, repel, and control pests in crops before and after harvest.
b) Influence the life processes of plants.
c) Destroy weeds or prevent their growth.
d) Preserve plant products.
Regulatory framework for plant protection products
In this case, active substances and plant protection products are regulated by European Regulation 1107/2009 and, in the case of Spain, by Royal Decree 971/2014, which regulates the evaluation procedure for plant protection products. This regulation specifies how a plant protection product must be registered, the characteristics of the dossier, the approval procedure for active substances, etc.
In an increasingly demanding regulatory environment, having specialized consulting in plant protection products is key to ensuring legal compliance, product safety, and market access.
Specifically, at Medical Devices Sur Consulting, we can assist you in the following ways regarding the marketing and regulation of plant protection products:
- Registration of active substances.
- Preparation of technical dossier.
- Assessment of submission of candidate substance for substitution.
- Comparative assessment.
- Evaluation of maximum residue limit of active substance.
Contact us and discover how we can help you ensure regulatory compliance of your plant protection products.