Identification of the product category is perhaps the most crucial step to comply with the Regulatory requirements in the European market. The identification process can be quite challenging as many products fall under two (02) or more categories and are affected by different Regulatory frameworks. Such products are referred to as borderline products. 

The primary criteria to recognize the borderline product is to understand its purpose and function, which may overlap with other product categories. Other relevant criteria are the product composition, product claim and also the overall presentation of a product.

If a borderline product falls within the scope of two (or more) regulations or Directives, one of the following three options is applicable:

• The product can be regulated under both/all Regulatory frameworks within the scope
• The product can be regulated under the most stringent Regulatory framework
• A commission/court can decide whether point 1 or 2 applies to the product

A few examples of the typical borderline products are as follows:

• Cosmetic and biocidal functions: hand cleaners, sunscreen products with insect repellent
• Medical and biocidal functions: insect repellents
• Medical and cosmetic functions: skin discoloration

Categorizing a product can be quite challenging but is essential. Identifying the product category, decoding the Regulatory requirements and registering/notifying the product under the right regulation or Directive ensures product compliance. One misleading claim can lead to unnecessary costs in product registration, delay in market entry or product recalls. Therefore, it is highly recommended that product manufacturers continuously stay informed about the developments in the Regulatory world and categorize their products accordingly. Assistance from a Regulatory expert like Freyr can help you in seamless product categorization and registration.

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