Product Regulation and Guidance Documents

Product safety is of the utmost importance to manufacturers. All raw materials are thoroughly assessed for impact on health, and occupational and environmental safety, to meet European and national legislation. Raw materials are selected according to strict quality criteria and manufacturers pay rigorous attention to regulation and manufacturing processes to ensure safety.

Tampons, feminine hygiene and disposable nappy products sold in the UK are regulated by the General Product Safety Directive (EEC Directive 2001/95/EC). Click here to view. To meet the requirements for this, manufacturers must have stringent procedures to evaluate the safety of raw materials, finished product and instructions for use.

The Government Department which oversees the General Product Safety Directive is the Department of Business Energy and Industrial Strategy (BEIS). Click here to visit their website.

AHPMA members stringently adhere to the UK Voluntary Code of Practice for Tampon Manufacturers and Distributors, which ensures a consistent approach to consumer information on safety including a warning and information on Toxic Shock Syndrome and correct use. The Code of Practice is available for use by any producer of any tampon or menstrual device and is recognised by UK government departments and retailers. The Code was originally developed in conjunction with the Department of Health and the Department of Trade and Industry (now BEIS). Note: There is a separate EU tampon code of practice for products sold within the EU but outside of the UK market. Different parts of the world may have other codes of practice and other national regulations may apply. View the AHPMA UK Voluntary Code of Practice for Tampon Manufacturers and Distributors.

Incontinence products are classified as medical devices and must meet the requirements of the existing Medical Device Directive (93/42/EEC) and/or the new Medical Device Regulation (2017/745) which came in to force on 25th May 2017, with a transition period up to May 2020, whereupon it will replace the Medical Device Directive. For details of the new regulatory framework click here.

Green or environmental claims can sometimes be misleading to consumers. The Department for the Environment, Food and Rural Affairs (DEFRA) has produced guidance for businesses on making ethical claims. Find it here: www.gov.uk/government/publications/make-a-green-claim