1. Budapest 26th april 2005 Seminar on Consumer Protection Protection of consumer health and safety : implementing experience and best practices of the EC legislation in Belgium Philippe Bauwin Belgian Federal Public Service Public Health General Direction 3

2. The European directive regarding general safety of products was transposed in Belgium law by the Royal decree of 9 th february 1994 regarding products and services safety. You will note that it covers not only products but also services

3. The consumer’s safety in Belgium is under the competence of the General Direction quality and safety of the Federal Public Service Economic Affairs Other Federal Services are competent for consumer’s safety concerning special categories of products Example for food: the Federal Public Service Public Health, Safety of the Food Supply Chain and Environment Example for medical devices: Federal Public Service Public Health General Direction 3 Medical devices dept Some products are borderline.We will see some examples.

4. In our law the concept of consumer was extended to the concept of user. This includes the use of equipment supplied by an employee to his workers to perform their job. Distributors duties : regarding information and post – marketing surveillance were also specified Various decrees to make the law effective were published.

5. A presumption of safety is given to products or services that are In conformity with european harmonised standards. Alternatives are listed in case harmonised standards are not available. A central contact point is defined to notify products or services.

6. The commission for consumer safety has an important advice role - regarding future regulations - regarding safety and health problems related to the use of products or services public. - regarding information campaigns that would be needed regarding products or services. - regarding health or safety promotion information actions intended for the costumer. It is in this commission that consumer organisations are represented.

7. Composition President Vice – president 9 representatives of professional organisations 6 representatives of consumer associations 3 representatives of workers organisation 9 experts One representative of each competent administration the coordinator of the central contact point

8. Examples of subjects treated by this commission. sound level of walkmans. sleeping goods involved in newborn sudden death ladder safety lift users safety contact lenses distribution including those for cometic purposes Specific regulations were published for various products and services.

9. Example of subject discussed by the commission for consumer’s safety : contact lenses. Some contact lenses are medical devices : those for vision correction. They are CE marked as medical device. Other contact lenses are only for cosmetic use : coloured lenses These are consumer goods.

10. The commission was informed by ophtalmologists of serious ophtalmic problems caused by cosmetic contact lenses. The main causes are : That these lenses are not distributed by opticians but by department stores. That these are used mainly by young people who are not well informed of the precautions needed when you wear contact lenses.

11. It appeared that there was also a problem with contact lenses distributed by department stores were no professional advice by an optician is available and without checking if there was a prescription by an ophtalmologist. The advice was that there was a need for selective distribution. Despite this advice no result was attained up to now due to the variety of stakeholders and regulations.

12. Stakeholders : opticians distribution chains pharmacists ophtalmologists manufactures distributors administrations

13. Regulations : medical device regulations Regulations regarding the profession of optician General safety regulations …

14. Example of the impact of the law on safety of products and Services in the health sector. sterilisation of medical devices in hospitals Gas distribution systems in hospitals. Various products are subject to specific directives that specifies everything that is needed to put safe products on the market. Example : cosmetic products or medical devices.

15. Nevertheless there are situations were no product is put on the market because the product is made in a hospital for its own use. Example : Reprocessing and sterilisation of reusable medical devices in a Hospital for its own use or production in-house of sterile intervention packs. The medical device directive does not aply because there is no putting on the market.

16. The general safety regulations apply. Consequence : Harmonised standards apply example EN554 regarding routine control and validation of steam sterilisation. EN 285 : technical specifications for large steam sterilisers. Example : Gas supply distribution system built by a hospital or under his responsibility for its own use. Again, altough medical gas distribution systems are normally medical devices, in this case ther is no putting on the market and the medical device directive does not apply. But : the general safety regulations apply Reference standard : EN 737.

17. In case of dammage in a situation like this the hospital would be liable if the reference standards were not applied and there is a relation between the incident and the non conformity to the standard.