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The development of chemical safety

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Role and obligations of the competent authorit – no.1 Safety in the use of chemicals at work.
July 16, 2022
Laboratory Hazard Assessment and Controls and Standard Operating Procedures
July 18, 2022

The development of chemical safety

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With a population of two million and an important chemicals industry, the country has a
long tradition of stringent attention to chemical safety and public health. This has been
reflected in laws concerning the management of chemical substances. Historically, the
competent public health authority has played a leadership role in the area.

Systematic monitoring of drinking-water began in 1923 with the establishment of
the Hygiene Institute of Ljubljana. The Institute’s activities expanded to include the
monitoring of rivers and wastewater as well as food and consumer products. In 1925,
a Chemistry Department was established within the Institute, with functions including
medico-chemical, technical-pharmaceutical and toxicological examinations.
The Department aimed to accelerate improvements in the quality of food and to alert
the population to poor and fake foodstuffs. It also advocated preventing the pollution
of clean mountain rivers with industrial effluents, showing that there was already
ecological awareness of one of the most important human needs: drinking-water.
Public health physicians and decision-makers were aware of the need to control for
foreign substances in food, especially because more and more synthetic pesticides
and fertilizers were being used. Control over this and certain other food ingredients
was regulated by the Law on Control of Foodstuffs.

The Department worked closely with Ljubljana municipality in supervising the market
and advised other state institutions on action to take in relation to the food laws.
The Hygiene Institute later broadened its responsibilities and continued to deliver
chemical hygiene activities until the 1990s. In the process of accession to the EU,
however, many activities related to environmental monitoring and food safety were
transferred to the ministries responsible for the environment and for agriculture,
respectively, and some of the Institute’s public health-related chemical safety
responsibilities were transferred to the newly established CORS.

The Medical Faculty of the University of Ljubljana, the Poison Control Centre, the
National Institute of Chemistry and the Jožef Stefan Institute have all played visible roles
in scientific research and the education of scientists and professionals in toxicology
and chemical safety.

It is common practice in chemical safety development for the government to be
constantly informed on all relevant topics, facts and figures in relation to chemicals.
Through transparent and evidence-based arguments, politicians have become more
aware of and confident in dealing with the subject, which is important given the key
role of political support. Such political support can be ensured by the permanent
raising of awareness among the competent people, including politicians, followed up
by well-considered and transparent operations.

In 1997, in preparation for the country’s accession to the EU, consideration was given
to placing the chemical safety coordination body under the jurisdiction of the Ministry
of the Environment, since at EU level chemical substances came under the Directorate
for the Environment while preparations were under the Directorate for Industry.
However, the field of chemical safety (including substances and preparations) remains
under the jurisdiction of the Ministry of Health. The Ministry of Agriculture, Forestry and
Food is the competent authority for plant protection products, while the ministries of
Health and the Environment are included in their registration process in accordance
with their relevant competences.

At that time there was no awareness of chemicals in general. The most regulated
chemicals were pesticides, which formed the main focus of the authorities and
nongovernmental organizations. Chemical safety and poisons were considered mainly
through the prism of pesticide safety. A wider awareness only developed later, when
the Ministry of Health took over the implementation of the acquis communautaire in
the field of chemicals. Thus pesticides were the vehicle through which chemical safety
developed in Slovenia.

The authorities became familiar with the system in chemicals and the area of plant
protection products through several EU projects during the process of accession to
the EU. Since then, a close relationship has been built between EU and Slovenian
experts.

Information on the implementation of chemical safety in Slovenia since 1991 is
presented below in chronological order.

In 1991, the government incorporated the Poisons Act of the former Yugoslavia into
its own legislation. This relatively advanced act focused mainly on pesticides, and
contained key elements from the European directives on the classification, packaging
and labelling of dangerous substances (Directive 67/548/EEC) (3) and dangerous
preparations (Directive 88/379/EEC) (9). The Act contained all the key elements of
these two directives referring to public health and the health of the environment,
including aspects such as carcinogenesis, teratogenesis and mutagenesis.

The
Ministry of Agriculture, Forestry and Food was made responsible for plant protection
products, although the Ministry of Health was included in the process of registering
such products in relation to their categorization in groups of poisons.

In 1996, the Ministry of Health began the further development of chemical safety to
include other chemicals in the framework of the pre-accession strategy of Slovenia to
the EU. The negotiations for membership of the EU were adopted by the government
on 21 November 1996.
A government resolution of 29 March 1996 laid the foundation for the development
of chemical safety with the involvement other sectors, starting with the preparation
of a harmonized scheme for monitoring the residues of plant protection products in
soil, water, plants, foodstuffs and drinking-water. The government stipulated that the
Ministry of Health should, by the end of 1996, establish an interministerial body for
the coordination and harmonization of work in the field of dangerous substances.

The government also ordered its informatics centre to prepare a proposal for an
electronic system to connect all institutions supervising the use of pesticides. Since
the implementation of national monitoring faced many drawbacks, the government
decided on 2 October 1997 that Slovenia should avail itself of the Programme of
Community aid to the countries of Central and Eastern Europe (PHARE)2

within the
scope of pre-accession preparations. On 18 February 1999, the regulation on the
monitoring of pesticides in foodstuffs and agricultural products developed in a PHARE
project was issued. However, the programme was never completely harmonized in all
elements of the field of the environment, as initially planned.
In 1995 and 1996, the Ministry of Health employed the first three civil servants to
develop the chemical safety law and a vision for chemical safety arrangements,
including capacity-building.

The Minister of Health published a decision on 22 May 1996 prohibiting the use of
atrazine and some other substances under the Poisons Act of the former Yugoslavia.
The implementation of this decision was an exercise in interministerial work by the
three ministries involved (Agriculture, Environment, Health and their competent
inspectorates). The Ministry of Health coordinated the implementation of the decision.

On 25 July 1996, the government issued a decision that:
– established the Intersectoral Committee on the Management of Dangerous
Substances led by the Ministry of Health and with the obligation of reporting to
the government; its first meeting was opened by the Secretary General of the
government, demonstrating high political support for the Committee;

− authorized the Ministry of Health to coordinate good laboratory practices activities;
− authorized the Ministry of Health to employ expert staff to support the competent
authority (future CORS) at the Ministry: three interns specializing in toxicology, two
experts in pharmacology and experimental toxicology and an expert on laboratory
analytics (forensic) to support the Poison Control Centre, all at the Faculty of Medicine
in Ljubljana; in addition, an internationally distinguished medical toxicologist was
employed at the Public Health Institute in 1997.

The National Assembly adopted a resolution on 27 September 1996 on the remediation
of the asbestos industry and the requirement for a report on the situation in the Mežica
Valley, a site contaminated by lead. Following the adoption of the Chemicals Act in
1999, further measures were coordinated by the Ministry of Health via the Intersectoral
Committee for Chemical Safety (the successor to the Intersectoral Committee on the
Management of Dangerous Substances).

The government considered the first report of the Intersectoral Committee on
the Management of Dangerous Substances on 5 February 1997. It supported the
Committee’s wish to attract representatives of more nongovernmental organizations
for further cooperation, such as science and research organizations, trade unions,
a representative of environmental nongovernmental organizations, the Consumers’
Association, government informatics centre and others (if necessary). Representatives
from the nongovernmental sector were not members of the Committee but had the
right to discuss and propose matters on the agenda without a vote. The government
ordered the Ministry of Health to provide funds for the work of the Committee.
On 5 March 1998, the decree on the prohibition of and restrictions on the production,
placing on the market and use of asbestos and asbestos-based products was issued.
The national asbestos management programme was also drafted.

The basic legislation on chemical safety (acts on chemicals and on chemical weapons)
was adopted on 29 May 1999. The Chemicals Act set the legal basis for interministerial
coordination via the Intersectoral Committee for Chemical Safety. The Committee’s
task was to prepare the national chemicals programme and to present the basis for
the preparation of the electronic system for chemicals. The area of chemicals was
regulated in accordance with all relevant EU regulations. Some specific elements
were preserved (maintenance of a register of producers of and traders in dangerous
chemicals; requirements for carrying out activities, including obligatory education in
chemical safety; obligatory reporting to the national authority).

On 29 August 1999, CORS was established as an authority under the Ministry of
Health on the basis of the Chemicals Act, its first director having been appointed
on 3 June 1999. The Office started operating three months after the adoption of the
Chemicals Act. The Ministry of Health harmonized its activities with other line ministries
and regularly proposed activities for consideration to the Intersectoral Committee on
the Management of Dangerous Substances, which operated until 2009. The need for
interministerial cooperation in the entire area of chemical safety remains substantial.
In 2008, the National Chemical Safety Plan 2008–2013 was adopted as a result of
cooperation among the sectors and with the EU through pre-accession mechanisms
such as PHARE.

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