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Regulatory Compliance services for Biocides

Biocidal Product Compliance services provided by QACS complement the antimicrobial efficacy testing services, offering comprehensive solutions for the compliance of your biocidal products with European and national requirements before their placement on the Greek market.

Regulatory Guidance

Before a biocidal product covered by the transitional provisions of Article 89 of Regulation (EU) 528/2012 is placed on the Greek market, a marketing authorisation from the competent authorities (EOF / Ministry of Rural Development & Food) is required. Our team fully supports the marketing authorisation process, undertaking guidance, preparation and submission of the biocidal product dossier, as well as continuous support to your company until authorisation is granted.

Since biocidal products fall under the REACH and CLP Regulations for chemicals, they must be accompanied by an up-to-date Safety Data Sheet (SDS), derived from a classification study. Labelling elements and the need for PCN notification depend on the information provided in the product’s SDS. The QACS team of experts supports the classification study and the preparation of the Safety Data Sheet for your product.

Article 45 and Annex VIII of the CLP Regulation introduce specific obligations for chemical mixtures classified for health or physical hazards. These obligations also apply to biocidal products and include the generation of a Unique Formula Identifier (UFI), its inclusion on the label, and the relevant notification to poison centres (PCN). The QACS team supports your product’s compliance by generating the UFI code and submitting the necessary information for PCN notification.

Compliance of the biocidal product label with the Biocidal Products Regulation (BPR), the Classification, Labelling and Packaging Regulation (CLP), as well as national requirements, is crucial prior to placing the product on the market. The QACS team provides Label Review services and guidance to ensure the compliance of your product’s label.

Why Biocidal Product Compliance Services Matter

Biocides Regulatory Services are essential for the industry, as they support mandatory actions required before a biocidal product is placed on the market—such as creating the SDS and a compliant label, submitting the PCN notification when required, and submitting the biocidal dossier to obtain marketing authorisation. With proper guidance, your company can successfully manage these actions, avoid errors and delays, and ensure that your products meet all regulatory requirements for lawful market placement.

Contact us – [email protected] – +30 210 29 34745

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