Phasing out biocidal products when the authorisation has expired or changed
Innehållsförteckning:
When an authorisation for a biocidal product has expired or been changed to such an extent that it has been given a new registration number, there are rules on phase out periods on how long you may sell, transfer or use the product.
The phase out periods for biocidal products are regulated in the EU Biocidal Products Regulation and the Swedish Pesticides Ordinance (2014:425). How long the phase out period is can vary between different products and depends on which rules the product is covered by. A product is subject to different rules depending on the active substances it contains and the status of the substances at EU level. The substances may be under evaluation in the EU review programme or be subject to approval or non-approval decisions. Since active substances are evaluated and approved for different product types, the product type of the product in question must also be taken into account.
Here you can find the European Chemicals Agency ECHA's database of active substances External link., where you can also see the status of the substances.
Standard times for the phasing out of biocidal products
For biocidal products that have been approved in accordance with the EU Biocides Products Regulation there is a sell-off period of a maximum of 180 days and an additional 180 days for end use. Since the phase-out periods are regulated directly in the regulation, information is listed on which approvals have been revoked or changed in the Swedish Pesticides Register .
For products approved under national regulation, the Swedish Chemicals Agency decides on phase-out periods.
The deadlines for biocidal products are published in Swedish Pesticides Register.
Phase-out periods for EU decisions to approve active substances
If a product has been on the market in accordance with national rules during the evaluation period for the active substance, certain transitional rules apply when the substance is subsequently approved at EU level. Once an active substance has been approved at EU level for the product type in question, you need to submit an application for approval in accordance with the EU Biocidal Products Regulation for products with the active substance if you want the product to remain on the market. The application must be received no later than the date of the substance approval in order for the product to continue to be available on the market during the time for evaluation of the application.
If you choose not to apply for authorisation according to the EU Biocidal Products Regulation, the deadlines for sale are 180 days and 365 days for the use of existing stocks after the date of approval of the active substance, according to the EU Biocidal Products Regulation. These phase out periods apply to products on the Swedish market for which authorisation has not previously been required in Sweden according to national rules, if one chooses not to apply for approval in accordance with the EU Biocidal Products Regulation. They also apply to products that have been authorised according to national rules if you choose not to apply for authorisation according to the EU Biocidal Products Regulation.
If the application in accordance with the EU Biocidal Products Regulation has been submitted on time, but has been rejected or the product authorisation has changed, the deadlines for sale are 180 days and 365 days for the use of existing stocks after the day of the authority's decision.
The products covered by the above phase-out periods are published in the Swedish Pesticides Register.
Shorter deadlines because of EU decisions on non-approval of active substances
These deadlines apply if the Swedish Chemicals Agency does not decide otherwise in the individual case. Decisions in individual cases are published in the Swedish Pesticides Register.
Information on active substances and their status.
Previous Swedish practice on the phasing out of pesticides that are no longer authorised
For biocidal products that contain active substances that are still being evaluated, but which have not yet been approved or banned at EU level, previous national practice are most often applied. The phase out period for such products is usually one year for sales and another year for end use. However, the phase out period for sales does not apply to the first stage of supply. Please note that this is only practice and that the Swedish Chemicals Agency can make a decision on phase out periods for each individual product. Such decisions are always published in the Swedish Pesticides Register: