S.L. 427.28 Art. 17Safety data sheet. Confidentiality of chemical names. S.L. 427.14 Safety of workers. Safeguard clause. Methods

(Deleted by: L.N. 221 of 2007) 18.1. Where the person responsible for placing the preparation on the market can demonstrate that the disclosure on the label or safety data sheet of the chemical identity of a substance which is exclusively classified as: - irritant with the exception of those assigned R41 or irritant in combination with one or more of the other properties mentioned in the fourth indent of regulation 13.2.3, or - harmful or harmful in combination with one or more of the properties mentioned in the fourth indent of regulation 13.2.3 presenting acute lethal effects alone, will put at risk the confidential nature of his intellectual property, he may, in accordance with the provisions of the Sixth Schedule be permitted to refer to that substance either by means of a name that identifies the most important functional chemical groups or by means of an alternative name. This procedure may not be applied where the substance concerned has been assigned an exposure limit by the European Community. Where the person responsible for placing a preparation on the market wishes to take advantage of confidentiality provisions, he shall make a request to the Director. This request must be made in accordance with the provisions of the Sixth Schedule and must provide the information required in the form in Part A of that Schedule. The Director may nevertheless request further information from the person responsible for placing the preparation on the market if such information appears necessary in order to evaluate the validity of the request. The Director, when receiving a request for confidentiality shall notify the applicant of his decision. The Director shall recognise a decision pursuant to a request for confidentiality taken by the competent authority of a Member State of the European Community, provided that a copy of such decision has been duly forwarded to him by the person responsible for placing the preparation on the Maltese market. Confidential information brought to the attention of the Director shall be treated in accordance with the provisions of the Dangerous Substances (Notification) Regulations.

19.1. These regulations shall apply without prejudice to other requirements deemed necessary to ensure that workers are protected when using the dangerous preparations in question, provided that this does not mean that the classification, packaging, and labelling of dangerous preparations are modified in a way not provided for in these regulations. 20.1. Where the Director has detailed evidence that a preparation, although satisfying the provisions of these regulations, constitutes a hazard for man or the environment on grounds relating to the provisions of these regulations, he may, on the advice of the Directorate responsible for chemicals within the Malta Standards Authority, provisionally prohibit the placing on the market of that preparation or subject it to special conditions. FIRST SCHEDULE for the evaluation of physico-chemical properties of preparations in accordance with regulation 8