Notification for products placed on the Maltese market

Background information

Various European Regulations and Directives, transposed into national legislation, require Member States to appoint a body or bodies responsible for receiving information on chemicals, detergents, biocides, plant protection products and cosmetics, including information on the chemical composition of such products, and for making such information available in cases of suspected poisonings. This means that this appointed body must have data on these types of products.

According to Article 45 of the CLP regulation "Member States shall appoint a body or bodies responsible for receiving information" including "the chemical composition of mixtures placed on the market and classified as hazardous on the basis of their health or physical effects". All this information shall be kept at the disposal of the appointed body.

This matter was also brought up during the project, supported by the United Nations Institute for Training and Research (UNITAR), concerning the "National Chemicals Management Profile Development and National Priority Setting in Malta". The National Profile raised two important issues: the need of data collection on chemical products, including fertilizers, where currently no information is available; and the need of establishing a poisons centre. According to the WHO, Malta is one of the four EU Member States that does not have a poison centre. The Medicines and Poisons Information Service, at Mater Dei Hospital (MDH), is providing a similar service to that offered by a poison centre, however, various important factors that enable the proper functioning of a poison centre are missing. One of these factors is the availability and accessibility to the right information. To be able to answer enquiries, the poisons information service needs to maintain a comprehensive collection of information about chemicals, pharmaceuticals, products, plants and venomous animals. It also needs to develop treatment protocols and guidelines in order to ensure that the information and advice given is consistent. Lacking a readily available source would mean losing precious time in trying to identify the contents of the product and this can have fatal consequences.

Moreover, when taking into consideration clinical toxicology, according to a report which was published as a result of the recommendations proposed by means of the UNITAR project, for years 2003 to 2007 an average of 174 patients, with an admission related to toxicology, were registered in the Hospital Activity Analysis Database of St. Luke's and Mater Dei Hospitals. It is estimated that the real figure is 250 patients a year, considering that it is estimated that data used captured 70% of the admissions only. For years 2002 to 2007 an average of 13 patients died a death related to toxicology. With this in mind it is of great importance to develop a system whereby data concerning chemical products is made readily accessible so that local hospitals can be a step ahead when dealing with chemical incidents.

Being the competent authority for the regulations concerning chemicals, detergents, pesticides and cosmetics, the Malta Standards Authority (MSA) is proposing to introduce a notification system of the products that are being placed on the market, including chemicals, cosmetics, detergents, fertilizers, plant protection products and biocides. Information on these products shall be submitted to the MSA and the latter shall keep this data at its disposal.

This notification mechanism is similar to the data collection system employed in several other EU Member States, such as Italy, Germany, Belgium and France where they all have established national databases on products and composition.

The person responsible for placing the product on the market shall send to the MSA information related to the full chemical composition, intended uses, type of use and general characteristics of the product. The submission of the data shall be made electronically so as to facilitate the process both for the notifier and the MSA. The responsible person shall also upload a copy of the label of the product and its safety data sheet. Since the safety data sheets are only for professional use and not for domestic use mixtures, the information therein on non-dangerous components is often lacking. Indeed in the database the chemical name for the dangerous components and the chemical family name for the non-dangerous components are required. This notification system shall also apply to the products found already on the market. The notification of products is to be staggered over a period of time. This one-time  notification system shall be free-of-charge.

By having this data bank, the MSA can contribute to the Medicines and Poisons Information Section, at MDH, by allowing access to the information for health prevention purposes and for toxicological emergencies. MSA shall guarantee the industry the necessary confidentiality of the information stored in the archive, hence the Medicines and Poisons Information at MDH, who will have access to the archive, shall ensure an acceptable level of confidentiality as well. The MSA may eventually provide the information to other authorities/departments for their institutional tasks upon request.

Scope

The proposed legal notice is necessary to appoint MSA as the body responsible for receiving information, including the chemical composition of the products placed on the market, which is a current requirement.

This Legal Notice shall apply as soon as possible. After the present legal notice will come into force, the products which are placed on the Maltese market for the first time shall become notified within 30 days as from the date of introduction into the Maltese market.

Due to the expected large number of products that shall become notified, products placed on the market before the date of entry into force of the present legal notice, shall be notified within a period of time as established by the proposed regulations.

In view of the above kindly submit any comments by mail by Monday 21^st March 2011.