With years of experience in chemical safety, we aim to support the regulatory compliance of chemical manufacturers, importers, distributors and downstream users.

Our company is specialised in the chemical safety field, providing safety data sheet preparation, review and Poison Centre Notification for hazardous mixtures.

Services

Safety data sheet creation/revision/update

Safety data sheet creation
According to the Act XXV of 2000 on Chemical Safety (Chemical Safety Act), activities involving hazardous substances/mixtures may be started on the basis of a safety data sheet containing the data of the substance or mixture used. The preparation of the safety data sheet is the responsibility of a competent person, who must take into account the specific needs of the customer, if known.  The safety data sheet may need to be revised in certain cases, and the reasons for this revision and the relevant information must be included in the document.

The compiler of the safety data sheet should take into account that the document should inform the user of the hazards of the substance or mixture. It should also provide information on the safe storage, handling and disposal of the substance or mixture. The document should enable the employer to identify hazardous chemicals in the workplace and assess the health and safety risks of workers using these substances.

The supplier shall provide the receiving party with a data sheet compiled in accordance with Annex II of the REACH Regulation and Regulation 2020/878/EU, which will be applicable from 1 January 2021. Data sheets prepared in accordance with Regulation (EU) No 2015/830 may be used until 31 December 2022.

The document must be provided free of charge in paper or electronic format at the time of the first delivery. The safety data sheet shall be provided in the official language of the country in which the substance or mixture is placed on the market, with content in accordance with the legislation of that country.

Safety Data Sheet revision/update
A review/update is required without delay if new hazard data become available, if new data become known that may affect risk management measures, or if the substance or mixture is subject to authorisation or restriction. The updated information must be provided to all previous recipients who have been involved with the substance or mixture in the previous 12 months

The electronic notification of mixtures – classified as dangerous on the basis of health or physical effects – placed on the market in Hungary requires the information contained in the safety data sheet. For more information on the notification of dangerous mixtures (PCN notification), click here.

 

Our company undertakes the preparation, review and updating of safety data sheets.

If you would like to use our service, please ask for a quotation!

Hazardous mixture notification /Poison Centre Notification/

Hazardous mixtures that are not included in the product register must be notified electronically to the State Health Administration.

From 1 January 2021, for all dangerous mixtures classified as dangerous for health or physical hazards, importers and downstream users placing on the market will have to notify via the European Chemicals Agency (ECHA) notification portal (PCN), in accordance with Article 45 of Regulation (EC) No 1272/2008 (CLP Regulation) and Annex VIII.

The notification obligation will be introduced in a phased system depending on the end use of the mixture:

      • from 1 January 2021 for mixtures intended for consumer and professional use,
      • from 1 January 2024 for mixtures for industrial use, and
      • from 1 January 2025 for mixtures already notified in the national system before the relevant deadlines.

Thus, if the product concerned has already been notified before the relevant deadlines, it will be possible to have exemption provided by the transitional period until 1 January 2025 at the latest.

Fees payable to the PCN Notification Authority:

for a new notification and updating: free of charge, except:

  • Italy: 50 Euro/year (any number of products)
  • Hungary: for a new notification: 16 000 HUF/ notification,

for a ‘new’ notification following a significant change in composition:

12 000 HUF/notification.

 

Our company undertakes PCN notification for hazardous mixtures.

If you would like to use our service, please ask for a quotation!

Request for quotation



    Contact us

    Expletive Pharma Kft.

     

    E-mail: info@sds-pcn.com

    Office:  2143 Kistarcsa, Móra Ferenc utca 105. Fszt.1.

    Company registration number: 13-09-186254

    Vat number: 23746875-2-13