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According to the European Trade Union Institute, one in three occupational diseases in Europe is due to exposure to chemical substances. Contact with hazardous substances in the workplace poses a high risk to those who handle them, but most accidents are completely avoidable.

The chemical industry must focus all its efforts on preventing risks to human health and protecting the environment, a task in which companies, institutions, and society as a whole must collaborate.

Protect and Prevent. This is our goal. But how can we achieve it? Through information and training. To achieve this, we have effective tools at our disposal, such as Safety Data Sheets (SDS).

Join us, and throughout the article, you will discover how SDSs can help us in the essential task of risk prevention in the chemical industry.

What is a Safety Data Sheet?

A Safety Data Sheet (SDS) is an accepted and effective method that contains relevant information for the recipient of chemical substances and mixtures. The SDS specifies the characteristics, properties, and hazards of a particular substance or mixture. It also covers handling, storage, transport, waste management, measures to be taken in a risk situation, and first aid advice. The SDS provides useful and necessary information for the company and workers who will use the product.

Labeling and Safety Data Sheets are harmonized information tools. They are designed to facilitate the understanding of the risks involved in handling a substance or mixture, allowing companies to implement safe working methods and training programs in risk prevention.

Chemical product manufacturers and distributors must prepare and send the SDS with the first shipment of any hazardous chemical product, and the employer is responsible for making these sheets available to workers.

Adaptation of SDS to New Legislation

Communication means making something known to someone, transmitting signals through a common code between a sender and a receiver. This common code is the key to understanding each other.

The introduction of the REACH and CLP Regulations has marked a turning point, a push in the important and essential task of risk prevention. These regulations allow us to define the properties of a substance, classify it as hazardous, and communicate the risks associated with its use.

REACH (Regulation (EC) No 1907/2006 of the European Parliament and Council) is the European Regulation on the registration, evaluation, authorization, and restriction of chemicals (Registration, Evaluation, Authorization, and Restriction of Chemicals).

It was approved on December 18, 2006, and came into force on June 1, 2007, representing a total reform of the legislative framework on chemical substances and mixtures in the European Union. REACH led to the creation of the European Chemicals Agency (ECHA), whose role is to manage the technical, scientific, and administrative aspects of the Regulation.

REACH requires companies (whether manufacturers, distributors, importers, or intermediate users) in the chemical sector to:

  • Protect human safety and health, and the environment.

  • Assess the risks arising from the use of chemical substances and mixtures.

  • Inform about the risks associated with hazardous substances and mixtures through Safety Data Sheets and the safety measures to be taken.

  • Register hazardous substances exceeding one tonne per year.

  • Comply with restrictions imposed by the Administration on the marketing of certain hazardous substances.

  • Collect information on the chemical substances and mixtures used by company workers in the Safety Data Sheets.

  • Ensure that company workers have access to the SDS.

At the international level, the United Nations has developed the Globally Harmonized System (GHS) to achieve legislation that harmonizes the classification, labeling, and packaging of chemical substances and mixtures.

At the beginning of 2009, Regulation (EC) No 1272/2008, better known as CLP (Classification, Labelling, and Packaging), came into force to ensure that international regulations were reflected in the EU regulations. Since June 1, 2015, previous directives have been repealed.

CLP requires chemical companies to:

  • Classify substances and mixtures based on new classes and categories.

  • Adapt the content of labels (aimed at the general population) and SDSs (aimed at professionals) according to new identified hazards.

  • Include pictograms, new hazard statements, and precautionary advice.

  • Consider exposure scenarios for substances requiring SDSs, manufactured or marketed in quantities equal to or greater than 10 tonnes per year.

  • Include risk control measures.

  • Notify ECHA of substances classified as hazardous or subject to registration under REACH, so they can be included in a public catalog.

In summary, we can say that the CLP and REACH Regulations contribute to:

  • Protecting employee safety and health.

  • Protecting the environment.

  • Promoting the free movement of substances among member countries (sale, transport, handling).

  • Providing transparency in information about substances and mixtures.

  • Complying with international obligations.

  • Regulating labels and safety data sheets.

  • Enhancing innovation within the sector.

Government Intervention in the Application of Regulations

Each Autonomous Community must assume the following obligations within its territorial limits:

  • Monitor, inspect, and control compliance with the provisions of the REACH and CLP Regulations.

  • Develop regulations when necessary.

  • Sanction companies that do not comply with the regulations.

  • If an action or decision by an Autonomous Community affects others, it must request a report from those potentially affected before taking any steps.

  • If the matter is very serious or urgent, the Central Government will take the reins of the situation and seek a solution in collaboration with the Autonomous Communities.

Compliance with Regulations

Each Member State adapts community-level regulations. However, the fact that the current legislative framework is defined through regulations and not directives limits the scope of action of the States. They can only intervene in defining how inspections and controls will be carried out and participate in European bodies.

Compliance with regulations is a shared task between the Ministries of Health and Social Policy and the Environment, Rural, and Marine Affairs, in coordination with the Autonomous Communities to ensure the implementation of what is set out in the REACH and CLP Regulations.

The European Chemicals Agency is an active agent that proposes plans and projects to ensure that the Autonomous Communities conduct controls correctly.

The protection of human health is one of the main points where the Regulations place greater emphasis. Therefore, the National Network for Surveillance, Inspection, and Control and the Rapid Information Exchange System on Chemical Products work hand in hand to ensure this.

As for environmental care and monitoring, the Sectoral Environmental Conference and the Network of Directors General for Quality and Environmental Evaluation are responsible.

Law 8/2010, of March 31, takes into account the sanctions regime provided in the REACH and CLP Regulations and contemplates the formation of a joint coordination body for the application of this law.

Finally, the Autonomous Communities and Ministries must present an annual report showing official inspections, supervisory activities carried out, planned sanctions, and other measures taken.

What Information Should a Safety Data Sheet Include?

A Safety Data Sheet consists of 16 sections. This specific detail can serve as a clue to know when we have an official document in front of us or not.

Below, you will find each section that must be completed:

  1. Identification of the substance or preparation and the company.

  2. Composition/information on the components.

  3. Hazard identification.

  4. First aid measures.

  5. Firefighting measures.

  6. Accidental release measures.

  7. Handling and storage.

  8. Exposure controls/personal protection.

  9. Physical and chemical properties.

  10. Stability and reactivity.

  11. Toxicological information.

  12. Ecological information.

  13. Disposal considerations.

  14. Transport information.

  15. Regulatory information.

  16. Other information, such as advice related to training, recommended uses, restrictions, supplier recommendations, written references, main data sources, and date of issue.

What Documentation Accompanies a Safety Data Sheet?

In some cases, an SDS must be accompanied by a Chemical Safety Report (CSR) for a substance. Therefore, the information in the SDS must be consistent with that included in the CSR and with that contained in the registration dossier.

Furthermore, under Article 31, paragraph 7, of the REACH Regulation, registrants and downstream users who are required to prepare a CSR must attach the relevant exposure scenarios in an annex to the Safety Data Sheet.

Solutions that Facilitate Compliance with CLP (eQgest)

The preparation of an SDS is subject to certain conditions:

  • When a substance or mixture is classified as hazardous (based on what is outlined in the CLP Regulation).

  • When a substance is classified as carcinogenic, mutagenic, or toxic for reproduction.

  • If it is a PBT substance, i.e., persistent, bioaccumulative, and toxic, or vPvB, very persistent, and very bioaccumulative (based on what is outlined in the REACH Regulation).

  • When there is scientific evidence that a substance has harmful effects on human health or the environment, as severe as in other cases.

  • In the case of substances or preparations not considered hazardous, but subject to authorization by REACH, published by the European Chemicals Agency.

  • When a preparation is not considered hazardous, but one of the substances poses risks to human health or the environment and is found in a significant proportion.

Mandatory Guidelines for Preparing SDS:

  • The text must be written in the official language(s) of the State(s) where the substance or mixture is marketed unless the Member State(s) concerned specify otherwise. It must also be clear and concise to facilitate understanding by professionals.

  • The sheet must be available for 10 years from when the substance is first marketed.

  • When a new version of the sheet is written, it must be stated with the date it was made.

  • The sheet is not mandatory when the substance or mixture is sold to the general public and is accompanied by sufficient information for the user to take the necessary measures concerning human health, safety, and environmental protection unless requested by an intermediate user or distributor.

  • Since very technical data is exposed, it is advisable that there be an expert in the company, such as the Occupational Health Department, to convey the information and answer users' questions.

Taking into account all the technical specifications and changes occurring in a constantly changing legislative framework is a meticulous task that requires effort, attention, and time from manufacturers and distributors in the chemical industry.

eQgest software offers solutions for anyone needing answers regarding compliance with legislation, managing all the processes described throughout the article with rigor and speed.

eQgest is a very efficient and affordable software tool for classifying substances, labeling, and generating safety sheets, ensuring compliance with new Community regulations.

If you want more information, feel free to contact us, without any obligation.