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2001-06-21 |
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Report Contents
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Introduction
The 1973 General Health Law and a 1999 MinSalud Decree require registration and special labeling for hazardous substances and products, as well as authorization from MinSalud before being manufactured, imported, sold or distributed. These laws also give the Ministry broad powers to ban or severely restrict the manufacture, importation or use of hazardous substances, including authority to order that substitutes be utilized in products or production processes. So far, MinSalud has only exercised its powers vis-à-vis pesticides, asbestos and some mining uses of mercury compounds. Also, the Central American Agreement on Transboundary Movement of Hazardous Wastes (see below) requires it Costa Rica to ban imports of hazardous substances that have been banned or severely restricted in their country of manufacture, or whose registration has been denied or revoked for human health or environmental protection reasons. Apparatuses, equipment and instruments that produce secondary or incidental radiation are subject to special controls dictated by MinSalud.
Defined Restrictions:
Existing Law - Regional Agreement on Transboundary Movement of Hazardous Wastes
NOTE: Although intended primarily as a Central American agreement to ban hazardous waste imports, the Agreement’s scope also includes "hazardous substances that have been banned or whose registration have been cancelled or rejected by government regulation, or voluntarily retired in the country where it had been manufactured, for reasons of human health or environmental protection." (See discussion under "Costa Rica: Transboundary Waste Controls.")
Law 5395 – General Health Law
Status
In force since 1973.
Covered Products
The Law itself addresses all products that may affect human health, but its provisions regarding hazardous substances mentions "toxic substances and products, and dangerous substances, products or objects of a radioactive, ignitable, flammable, corrosive, irritant or other character declared hazardous by the Ministry, with risk or damage to the health or the life of people."
Basic Obligations
All Activities Subject to MinSalud Rules and Approvals
Article 239 states that no natural or legal person can import, manufacture, handle, store, sell, transport, distribute or supply hazardous substances without "strict compliance" with the dictates of MinSalud. Article 241 forbids "the issuance and supply" of hazardous substances and products that do not comply with registration, labeling and packaging rules set out by MinSalud.
Ban/Restriction Authority
Article 252 states that the Ministry can, in the name of protecting human health, deny permits for the importation, manufacture, sale or supply of "substances, mixtures of substances, products or mixture of products excessively toxic" or capable of causing "serious harm" to humans. This authority also applies to "objects or goods" that have caused repeated accidents or which have been declared hazardous by the Ministry. The Ministry can also order the product’s withdrawal from the market, ban its importation, sale, application or distribution, or order changes in its composition or structure. Last but not least, it can order changes in the use of "certain primary material causing the hazardousness of such goods."
Risk Avoidance/Minimization
Article 240 states that all persons engaged in the above listed activities involving hazardous substances must ensure that the operations "eliminate or diminish as much as possible the risk to health and safety of people and animals exposed to the risk or danger in their work, ownership, use or consumption" of the substances in question.
Labeling
Article 241 says that all hazardous substances and products must include labeling in Spanish that includes "pertinent symbology" (i.e., hazard classification and/or warning symbols), and information on the nature of the product, its risks, its contraindications and antidotes if needed.
Ban on Sale to Minors
Sale or supply of all hazardous substances, mixtures, products or objects to minors (in Costa Rica, under 18 years old) is prohibited.
Products Emitting Secondary or Incidental Radiation
Natural or legal persons that import, sell, distribute, transport or utilize apparatuses, equipment and instruments that produce secondary or incidental radiation are subject to special controls dictated by MinSalud based on its estimation of the health impact on humans.
Decree 28113-S – Regulations for the Registration of Hazardous Products
Status
In force since September 1999.
Covered Products
Any product deemed hazardous according to the "Guide to the Classification of Hazardous Products" included in Annex I (see explanation below) or has been so declared by MinSalud. Explicitly excluded from the Decree’s scope are (1) human and veterinary medicines; (2) industrial and household pesticides; (3) agrochemical formulations; (4) narcotic and psychotropic substances; (5) chemical products utilized as food additives; (6) products or apparatuses that emit radiation; (7) chemical, biological and similar substances for agricultural use; (8) laboratory reactants.
Basic Obligations
Registration
The manufacture, importation, storage, distribution, supply, sale, use or transport of hazardous products is only permitted when the product has been registered beforehand with MinSalud, and MinSalud will only grant registration to those entities which have a Sanitary Authorization for their operations issued by MinSalud.
There are three types of registration:
(1) hazardous products for wholesale or retail sale imported or produced within Costa Rica. These are divided into two subgroups:
a. products with a CAS (Chemical Abstract Service) number: these can be registered simply by completing the form outlined in Annex 2;
b. products without a CAS number: these must not only fill out the form in Annex 2, but also include a Material Safety Data Sheet (MSDS) as outlined in Annex 3;
(2) registration based on an existing registration: when a hazardous product is essentially identical to one already registered by the registrant (i.e., same substance or formulation involved, but different brandname), simple referral to the existing registration number suffices;
(3) the hazardous product in question is utilized in Costa Rican production processes as a "primary material" (i.e., as a production process input): these must only be registered the first time they are used, via the form in Annex 2 and accompanied by a MSDS when the product lacks a CAS number.
Registration for hazardous products used as primary material is valid indefinitely unless MinSalud cancels or revokes it. Revocation or cancellation occurs when MinSalud determines that an entity has not complied with all the requisites of relevant health and environmental regulations in force, or when new technical information is available that leads MinSalud to believe that it will pose human health risks.
Imports
Products for which the importer can show prior registration with MinSalud can be released from Customs without specific authorization from MinSalud. The Directorate-General of Customs will periodically supply MinSalud with lists of such imports for surveillance purposes.
Material Safety Data Sheets (MSDS)
For products without a CAS number intended for sale or for use as a primary material, a copy of an MSDS developed consistent with the International Standards Organization (ISO) norms and meeting the minima of the Decree’s Annex 5 is required to be submitted as part of registration documentation and must accompany the product. If MSDS is not in Spanish, the foreign language MSDS may be submitted if accompanied by a long form specified in Annex 5 detailing what is in the MSDS.
Prohibitions
The sale, transfer or donation of a hazardous product is prohibited when it has been imported by a "national industry" as a "primary material" (production process input). Also prohibited is any activity that implies contact with hazardous products by (1) minors (under 18 years of age) that do not have permission from the competent entity; (2) people not "apt" (trained) for activities involving the particular type of product; (3) pregnant or lactating women when the product in question has a label stating that it is hazardous for pregnant women or children.
Further Information
MinSalud is authorized to demand further technical data from registrants when it deems it necessary.
Classification
As it clearly states upfront, the "Guide for the Classification of Hazardous Products" in Annex I of the Decree merges the technical classification criteria (such as LD-50 toxicity test results) in U.S. Code of Federal Regulations (CFR) Title 40 with the UN Recommendations on the Transport of Dangerous Goods. All hazardous products are first grouped into one of nine classes:
Class 1 Explosives
Class 2 Gases
Class 3 flammable or combustible liquids
Class 4 solids (those flammable or subject to spontaneous combustion, or emit flammable gases when in contact with water)
Class 5 oxidants or
Class 6 toxic and infectious substances
Class 7 radioactive substances
Class 8 Corrosives
Class 9 Miscellaneous
Labeling
All hazardous products must bear legible labels in Spanish, glued or printed on the product’s packaging (or in an information sheet accompanying the product), bearing the information in Annex 4 and one of the hazard classification symbols from the UN system or the European Union’s (EU) system.
Issues of Concern and Comments
"Hazardous product" is defined in this Decree as "any product, substance or object of a toxic, combustible, ignitable, flammable, radioactive, infectious, irritant or corrosive character, according to criteria detailed in Annex I, or other [product, substance or object] declared as such by the Ministry." This is essentially extracted from Article 239 of the General Health Law (5395).
The principle legal base for this Decree is the General Health Law (5395).
This Decree derogates Decree 24867-S ("Regulations on the Risk Classification of Hazardous Products") and Decree 26805-S ("Regulations on the Registration and Control of Hazardous Products"). These former instruments explicitly applied to wastes, whereas the new Decree never uses the term "waste."
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