ESLP quality label and charter
- The ESLP label is a quality label created exclusively for proprietary medicinal products based on specific strains and sold in pharmacies.
- The ESLP label is assigned on spontaneous application.
- The ESLP label focuses on the fact that each strain in the product is specific and includes:
- Three levels of denomination for a specific strain: genus, species, strain.
- Registration number in a "strain bank" in Belgium or abroad.
- The quality label is assigned after qualitative and quantitative microbiological analyses have been carried out by an independent laboratory: Genalyse Partner SA for the label from 2022 to 2023.
- The products are sampled randomly in a pharmacy or a pharmaceutical wholesaler.
- The ESLP label 2022 to 2023 certifies that the strains present in the product concerned are specific, live and present in sufficient quantities in accordance with the information available on the product packaging.
- ESLP 2022-2023 label specifications:
- Provide proof of delivery/sample of each strain by the company that produces the specific strains.
- An initial quantitative analysis certifying that the specific strain (s) concerned are live and present in sufficient quantities (maximum 1 log difference from the amount stated on the packaging and in the instructions for the proprietary medicinal product).
- A second quantitative analysis conducted six months later certifying that the specific strain (s) concerned are live and present in sufficient quantities (maximum 1 log difference from the amount stated on the packaging and in the instructions for the proprietary medicinal product).
- Qualitative analysis with strain identification (DNA).
- The Scientific Committee includes a panel of experts which, after receiving the results from the mandated Laboratory, decides whether to grant or refuse the ESLP label for the submitted product.
- The Scientific Committee has sole authority to grant or refuse the label and any ESLP persons that are not members of the Scientific Committee do not participate in the work of the Scientific Committee. Members of the Scientific Committee have completed a non-conflict of interest form.
- The Secretary General and the ESLP daily management delegate are not members of the ESLP Scientific Committee.
- The mandated independent laboratory invoices the costs of analysis directly to companies applying for the ESLP label.
- The ESLP quality label is exclusively for products distributed in pharmacies.
- Applications are freely submitted to the ESLP by manufacturers of Lactobacilli, Bifidobacteria etc. strains.
- The ESLP label is assigned once a year at the year-end provided that the administrative costs for obtaining the label have been paid.
- The results are reported in the press as well as to the companies involved.
- The ESLP label does not provide in any way a quality scale between labelled products nor does it disqualify products that do not wish to participate in the trials proposed for granting the label. It has no health claim value.
- Any company whose product is labelled undertakes to respect in its communication the limitation rules relating to the strictly specified ESLP labelled product and a strictly defined geographical area.
- Applications to obtain the ESLP label must be submitted to the secretariat of the ESLP League.
- Analysis criteria of the ESLP label can change based on available criteria issued by authoritative national/international scientific groups.
- Companies seeking to obtain the label are committed to providing the information and elements necessary for the successful completion of its mission within the specified time and undertake to pay the introduction/application administration fees on time.