As far as the legal instruments are concerned, we can say that, on the one hand, their volume is too large, their transparency leaves a lot to be desired, and several pieces of regulation are still decidedly paternalistic. On the other hand, although there are few unregulated aspects of chemical safety, the quality of regulation differs, it is fragmented, supervision rights are split between several authorities, and supervision in general is not effective enough. That said, we must also state that Hungary has taken significant steps towards adopting European Union (EU) and OECD regulations regarding chemicals, and the process of legal harmonisation is well under way.
The formation of civil organisations that aim to promote chemical safety has begun, and these have started active participation in efforts to establish chemical safety. At the moment, their participation in the legislative process, and the impact analyses preceding the introduction of new regulations is only sporadic, and they often feel that they do not receive adequate support from the government.
Detailed regulation in accordance with the more general provisions of this decree is actually achieved by a decree issued by the Minister of Agriculture. This has three main sections:
This decree regulates the categorisation of pesticides (on the basis of toxicity, public health risk, risk to fish and bees), their packaging, labeling, the scope of those who are allowed to obtain them, the training requirements necessary for working with them, and the general and detailed rules governing their transport, storage, usage, and disposal.
Separate decrees govern the usage/handling of substances used for extermination (insecticides, rodenticides, and repellents).
The most significant elements of regulation:
The tasks performed by the national and county (regional) institutes of the NPHMOS include – among others – the following: registration and notification of substances, registration and supervision of activities, supervision concerning technical and technological issues, supervision of compliance with regulations governing (the medical aspects of) a person's fitness for a particular job, etc. If regulations are breached, sanctions may be enacted. If the provisions of this decree are breached, the authority that issued the license may
a) revoke the activity or nation-wide sales license it issued;
b) restrict production;
c) prohibit the activity – without actually revoking the license – until a specified future date, or until certain specified conditions are met;
d) initiate legal proceedings in accordance with the general rules governing procedures used to deal with legal transgressions, or, in certain cases specified by separate regulations, may initiate criminal procedures.
Sanctions a)-d) mentioned above may be used together.
Besides the aforementioned sanctions, the NPHMOS may also levy labour protection fines up to a maximum of 3 million HUF in certain aggravated cases of breach of regulations pertaining to the conditions of work, according to statute No. XCIII of 1993 (the so-called Labour Protection Act).
Regulations will soon be introduced governing the so-called Prior Informed Consent (PIC) procedure formulated in accordance with the London Guidelines.
The essence of the regulation is that only food additives approved by the Minister of Welfare may be used to produce foodstuffs. The setting up and operation of production facilities is also regulated, as is the obtainment of a production license for a new additive. The most important criteria of using food additives is that they may not pose a risk to consumers' health, and, in accordance with accepted purity requirements, may only be used in justified cases and quantities.
Testing of imported food additives to ensure that they pose no risk to public health is also regulated.
Also regulated, is the way in which food additives – and other ingredients – must be noted on the packaging of foodstuffs.
The list of permitted additives, their scope of use and their concentration are specified by the provisions of the Hungarian Food Register. Production and use of additives not mentioned in the Hungarian Food Register is conditional upon obtaining the appropriate permit, which requires the applicant to submit specified data.
Oversight is the role of regional centres for veterinary and food safety, the institutes of the NPHMOS, and the National Consumer Protection Inspectorate.
New regulations concerning veterinary products, introduced in 1996, conform to EU norms.
The transport of dangerous products is regulated by international agreements – on a branch-by-branch basis – Hungary has signed. With respect to transport by road, rail, and inland water, the Hungarian legal system specifies that the provisions of international agreements should be applied to internal (domestic) transport too, unless they contradict other regulations. It is important to note, that these provisions apply only to products (substances, objects, wastes) whose transport is considered dangerous.
When Hungary joined international agreements, these were usually promulgated by high-level regulations, which delegated the task of formally announcing the agreements and the transport regulations contained in their annexes (including their modifications, which happen about once every two-three years), plus the task of signing bilateral agreements, to the MTTWM.
The regulations governing the transport of dangerous products also include the rules of expediting them for transport (e.g. the material tests necessary to determine whether the product can be transported, classification according to the degree of danger in accordance with relevant rules, selection of appropriate packaging materials and transport vehicles and the labeling thereof, rules specifying the necessary papers and documents, regulations governing packages and containers, their manufacture, labeling, and inspection, etc.).
Official tasks pertaining to classification (with the exception of explosives), containers and other modes of packaging have been delegated to the National Technical Safety Inspectorate (NTSI), which is under the supervision of the MITT. Classification of explosives is done by the National Mining Authority.
Approval of vehicles (based on the expert opinion of the NTSI), the issuance of certificates proving compliance, and of vehicle drivers' ADR training certificates, is the task of the National Transport Inspectorate (NTI), which is under the supervision of the MTTWM. Regulating mobile sources of air pollution also falls under the authority of the MTTWM.
According to regulations currently in effect, implementing agreements is the task of the MTTWM, which also takes part in the work of international organisations aimed at updating regulations, and regulates and supervises tasks pertaining to transport in general. The Ministry does not have the power to regulate tasks pertaining to expedition, the effective regulation of which has yet to be achieved.
The main purpose of the decree is the regulation and supervision of activities pertaining to production, management, neutralisation, etc. It regulates all activities involving hazardous wastes, and specifies the necessary conditions for import, export, transit, and work performed under contract for foreign entities. It also regulates the records to be kept on hazardous wastes, and the transmission and accessibility of the data, allowing wastes to be traced, thereby ensuring completeness of information regarding their life-cycle. A government resolution addresses the need to formulate special rules to deal with hazardous wastes that require special treatment, in particular, pesticides and medical wastes. A directive issued by the Minister of Health governs the records to be kept on, and the neutralisation (disposal) of hazardous wastes generated by health institutes.
Applied criteria: according to the definition used by the decree, waste must be considered hazardous if it, or any of its components or transformation products possesses at least one of the dangerous properties defined in the annex of the decree, and the dangerous component is present in a concentration that poses a risk to living things, human beings and their health, or any element of the environment, or if it has a harmful effect if not stored and handled properly.
The criteria for classifying waste as hazardous are defined by the governmental decree. Hazardous waste may only be brought into the country for the purposes of further use, and only if the National Environmental Protection Inspectorate (NEPI) has approved this together with the NPHMOS. All aspects of supervision are handled by the NEPI and the NPHMOS.
The governmental decree issued in 1996 requires further modernisation (EU harmonisation).
To summarise, we must note that as far as the legal instruments regulating
chemical safety are concerned, older regulations, formulated before the
process of legal harmonisation began, and newer, modern regulations that
conform to EU norms, exist side-by-side. Continuation of legal harmonisation
according to the timetable drawn up by the government, and – also in accordance
with a government resolution – the passage of an "umbrella act" aimed at
regulating chemical safety in a comprehensive manner, are of vital importance.
This latter will make legal regulation simpler, clearer, more transparent,
and will ensure conformity with the legal system of the EU and OECD regulations.