BRAZILIAN REGULATORY FRAMEWORK IMPLEMENTATION OF GHS

BRAZILIAN REGULATORY FRAMEWORK IMPLEMENTATION OF GHS

Source: IBGE Instituto Brasileiro de Geografia e Estatística - 2010 AMAZONAS STATE CAPITAL MANAUS SÃO PAULO STATE CAPITAL SÃO PAULO

Source: (http://www.ibge.gov.br/english/presidencia/noticias/noticia_impressao.php?id_noticia=22651) Eight Federation Units concentrate 77.8% in contribution to GDP In 2010, only eight Federation Units concentrated 77.8% of the Brazilian GDP: São Paulo (33.1%), Rio de Janeiro (10.8%), Minas Gerais (9.3%), Rio Grande do Sul (6.7%), Paraná (5.8%), Bahia (4.1%), Santa Catarina (4.0%) and the Federal District (4.0%). The ten states with the lowest GDP accounted for 5.3% in contribution and all of them were in the North and Northeast regions: Rio Grande do Norte (0.9%), Paraíba (0.8%), Alagoas (0.7%), Sergipe (0.6%), Rondônia (0.6%), Piauí (0.6%), Tocantins (0.5%), Acre (0.2%), Amapá (0.2%) and Roraima (0.2%). The intermediate group, formed by nine states, contributed with 16.9% of the GDP. Goiás, Pernambuco, Espírito Santo, Ceará, Pará, Amazonas, Mato Grosso, Maranhão and Mato Grosso do Sul were in that group. All of them had a contribution from 2.6% to 1.2%. Pará and Espírito Santo were the states that most advanced in the 2002-2010 series, increasing 0.3 p.p. and 0.4 p.p. in contribution, respectively. Next, Mato Grosso and Maranhão came with a gain of 0.2 p.p., and Goiás, Pernambuco, Ceará, Amazonas and Mato Grosso do Sul advanced 0.1 p.p. in contribution. The intermediate group was a highlight in contribution, increasing 1.5 p.p. in relation to 2002 (15.4%). The group of the ten states with the smallest GDP gained 0.3 p.p. in contribution in relation to 2002 (5.0%), while the group of the eight greatest GDP lost around 1.9 p.p. in contribution (79.7% in 2002)

Source: IBGE www.ibge.gov.br/home/estatistica/indicadores/pib/defaultcnt.shtm Brazilian GDP (2012): US$ 2,20 trillion In 2012, compared to 2011, the expansion was of 0.9%, due to the 0.8% rise in the value added at basic prices and to the 1.6% growth of the taxes less subsidies on products. Services were the positive highlight (1.7%), whereas agriculture and livestock farming (-2.3%) and the industry (-0.8%) decreased. Thus, the GDP in current values reached R$ 4.403 trillion in 2012. The per capita GDP achieved R$ 22,402, remaining virtually unchanged (0.1%) in relation to 2011.

Brazilian Regulatory Framework Brazilian Legal System Federal Constitution Ordinary Laws Decrees Regulatons

Brazilian Regulatory Framework Brazilian Regulatory Framework Principles of Protection to the Environment and Public Health Creates obligations and provides for the jurisdiction of public departments and bodies Specifies and clarifies provisions of the law Procedures and penalties

General Rule Chemicals ILO 170 - Federal Decree 2657/98 (a) the term chemicals means chemical elements and compounds, and mixtures thereof, whether natural or synthetic; (b) the term hazardous chemical includes Brazilian Regulatory any chemical Framework which has been classified as hazardous in accordance with Article 6 or for which relevant information exists to indicate that the chemical is hazardous; (c) the term use of chemicals at work means any work activity which may expose a worker to a chemical, including: (i) the production of chemicals; (ii) the handling of chemicals; (iii) the storage of chemicals; (iv) the transport of chemicals; (v) the disposal and treatment of waste chemicals; (vi) the release of chemicals resulting from work activities; (vii) the maintenance, repair and cleaning of equipment and containers for chemicals;

Status of the Harmonization in Brazil ABNT Provides for the rules and guidelines for labeling and information on chemicals (data sheet and FISPQ) about safety health and environment. (Sanitation Products registered with ANVISA are under the surveillance of ANVISA only). ABNT (14.725) was updated in 2010 and it is compliance with principles of GHS. Provisions of such rule applies mainly to raw material and active ingredients, in relation to the terminology used, risk classification, labeling and data sheet information. (ABNT/CB- 10)

Brazilian Regulatory Framework Chemicals Brazilian Regulatory Framework 1 Late 80 s and 90 s with the changes from the military regime to democracy; the structure of the government and the forms to exercise the so-called "police power, safeguarding citizens' health, morals, safety, and welfare has cause severe changes to Brazilian Legal Scenario. 2 Brazilian Green Revolution - Increase of the extensive agribusinesses the 70 s and 80 s, as well as the indiscriminate use of pesticides, chemicals and fertilizers by farmers, in special on the crops of soy, wheat and rise. 3 - Federal Law 7,802/89 Chemicals Policy. Provides for: (i) rules for manufacturing, import, distribution, labels, information on adverse consequences, handling and posology of chemicals for agribusinesses and silviculture purposes; (ii) authorization and permits; (iii) registration of products; (iv) prohibited hazardous active ingredients and chemicals, as well as (v) joint jurisdiction of Ministry of Agriculture, Ministry of the Environment and Ministry of Health (this one for public health matters only) for the issuance of licenses, permits and registration (as well as for the inspection and control).

Brazilian Regulatory Framework Chemicals Brazilian Regulatory Framework 4 Ministry of Health Sanitary Policy - Consumer Goods, Sanitizing Products (Cleaning Products, Pest and Disease Control Products (home use), desinfectans. 5 Sanitary Regulatory Agency - ANVISA - (i) rules for manufacturing, import, distribution, labels, information on adverse consequences, handling and posology of Consumer Goods, Sanitizing Products (Cleaning Products, Pest and Disease Control Products (home use), desinfectans; (iii) registration of products; (iv) prohibited hazardous active ingredients and chemicals.

Brazilian Regulatory Framework Chemicals Brazilian Regulatory Framework 4 Ministry of Health Sanitary Policy - Consumer Goods, Sanitizing Products (Cleaning Products, Pest and Disease Control Products (home use), desinfectans. 5 Sanitary Regulatory Agency - ANVISA - (i) rules for manufacturing, import, distribution, labels, information on adverse consequences, handling and posology of Consumer Goods, Sanitizing Products (Cleaning Products, Pest and Disease Control Products (home use), desinfectans; (iii) registration of products; (iv) prohibited hazardous active ingredients and chemicals.

Brazilian Regulatory Environment Chemicals Brazilian authority in charge of chemicals is defined by the relevant use of such chemical, for example: 1 - Food, drugs and consumer products (cosmetics, health related products and sanitation products) Ministry of Health ANVISA. 2 - Fertilizers, herbicides, agriculture commodities, agriculture related products and veterinarian products Ministry of Agriculture - MAPA. 3 - Herbicides and chemicals not controled by MAPA, mainly for silviculture or timber products Ministry of the Environment - IBAMA. 4 - Chemicals used as raw-material (active ingredients) for the manufacturing of the products listed above shall follow specific rules of each one of the respective agencies. ABNT (brazilian association of technical ruling) provides for the technical rules for the handling and use of such chemicals, under the perspective of the safety and health regulation and environmental rules (MSDS).

Ministry of Health ANVISA Regulatory Sanitary Agency of the Ministry of Health HAS JURISDICTION OVER manufacturers formulators distributors and importers of consumer products (defined as sanitation products ) (desinfectantes, pesticides and cleaning products in general) ALSO APPLY: Consumer Code Technical responsibility rules; Environmental laws; Ministry of Justice (controlled chemical products) permits; and Ministry of Army (explosive products) permit.

Ministry of Health ANVISA Rules provide for a classification of sanitation products in general, in view of their relevant risks to human health and to the environment Such classification takes into consideration: (i) the use (and restrictions for the use); (ii) the place of use; and (iii) purpose of use.

Ministry of Health ANVISA Rules provide for a classification of sanitation products in general, in view of their relevant risks to human health and to the environment Class I: exempt from registration, but requires an enrollment and communication to ANVISA with the characteristics of the products, labeling containing use and handling instructions, as well as, adverse consequences; Class II: requires registration, with the approval by ANVISA of the products, labeling containing use and handling instructions, as well as, adverse consequences. I. II. III

ANVISA - Regulatory Provisions ANVISA Registration of Products Main Aspects: Registration (validity of 5 years) Labeling (applicable to Class I and II): No pictogram required; Braile language; Adverse consequences and warnings; Indication of technical responsible; Call center

Ministry of Agriculture MAPA Ministry of Agriculture HAS JURISDICTION OVER manufacturers formulators distributors and importers of fertilizers herbicides agriculture commodities agriculture related products and veterinarian products ( ALSO APPLY: Consumer Code; Technical responsibility rules; Approval and analysis of toxicity and ecotoxicity analysis by Ministry of the Environment and ANVISA; Environmental laws; Ministry of Justice (controlled chemical products) permits; and Ministry of Army (explosive products) permit.

Ministry of Agriculture MAPA Chemicals used in the agribusiness are subject to registration with MAPA, in view of the risks to human health and to the environment Raw material: technical ingredient, active ingredient of the formula; Product: requires registration of MAPA, with relevant prior approval of ANVISA and Ministry of the Environment, of the products, labeling containing use and handling instructions, as well as, adverse consequences. Products are classified from the most to the least toxic.

MAPA - Regulatory Provisions MAPA Registration of Products Main Aspects: Registration (no term of validity); Labeling must contain list of information provided by the Law; Pictograms required (Warning and Danger); Adverse consequences and warnings; Indication of technical responsible; Call center. I. II. III

A research done in 2007 showed that many farmers, and workers, ignore the color classification of the product. (red = extremely toxic; yellow = very toxic; etc). In addition, such research concluded that 75% of farmers interviewed DO NOT read the labels and none were able to define and explain at least 5 (out of 14) pictograms used to instruct users. Source: A.V. Waichman, E. Eve, N.C.S. Nina, Do farmers understand the information displayed on pesticide product labels? A key question to reduce pesticides exposure and risk of poisoning in the Brazilian Amazon, Crop Protection, 2007

Brazilian Regulatory Environment IBAMA Ministry of the Environment HAS JURISDICTION OVER manufacturers formulators distributors and importers of chemicals (pesticides, herbicides, wood protection and other biocides) not used in agribusinesses ALSO APPLY: Consumer Code; Technical responsibility rules; Approval and analysis of toxicity by ANVISA; Ministry of Justice (controlled chemical products) permits; and Ministry of Army (explosive products) permit.

Regulatory Provisions IBAMA Registration of Products Main Aspects: Registration (no term of validity) Labeling must contain list of information provided by the Law; Pictograms required (Warning and Danger); Adverse consequences and warnings; Indication of technical responsible; Call center EXEMPLO I. EXEMPLO II. EXEMPLO III

Status of the Harmonization in Brazil In Brazil, the Ministry of Development, Industrialization and Foreign Trade ( MDIC ) is in charge to regulate this matter. A Bill of Law Decree to make the GHS enforceable in Brazil was drafted by MDIC and is currently being reviewed by the Chief of Staff of the Executive Body.

Status of the Harmonization in Brazil Anvisa has a Working Group to review that. Meeting in April 2012. Ministry of Labor NR 26 (GHS and OSHA)

Regulation by the Ministry of Labor NR 26 issued by the Ministry of Labor on May 21, 2011 NR 26 issued by the Ministry of Labor establishes labeling obligations for suppliers of chemical products used in work environments; Such rules are in accordance and make express reference to the GHS; According to NR 26 the label must include essential information about the risks to the employees health and safety; The Ministry of Labor has the authority to establish rules to protect the health and safety of workers in their work environment (Decree Law # 3214/1978); NR 26 is addressed to and enforceable against both suppliers and employers (Decree 2657/1998; Convention # 170 of the International Labor Organization);

Regulation by the Ministry of Labor According to NR 26, the employer must ensure that all chemical products used by the employees are labeled in accordance with NR 26, and therefore in accordance with GHS; If the supplier fails to label the product properly, the employer remains responsible for the compliance with NR 26. Instead of labeling the product, the employer may use an alternative way (e.g. to provide training and to put signs in the workplace with the missing information); MSDS Safety Data Sheet in Brazil it is regulated by ABNT.

Regulation by the Ministry of Labor NON-COMPLIANCE BY EMPLOYER RISKS Administrative Penalty R$4,000 per infraction Direct responsibility for damages in the event of an occupational disease or accident BY SUPPLIER BOTH SUPPLIER AND EMPLOYER Penalty for Sanitary Infraction (articles 57 and 66 of Law # 6360/1976) Class action by the Public Attorney s Office for Labor Affairs

Status of the Harmonization in Brazil On top of general rules for chemicals, ANVISA has jurisdiction to control and legislate over regulations for the implementing the GHS for cleaning products, pest management and disinfectants. The Department of Sanitation Products of ANVISA is reviewing the labeling and registrations rules applicable to the products under its surveillance, as well as training its agents to the GHS provisions. According to ANVISA, the deadline for the revision of the regulation on the registration and labeling of sanitation products expires on December 31, 2011. (There is not a Public Consultation or Public Hearing scheduled to discuss this matter)

Status of the Harmonization in Brazil Brazilian companies who export their products (mainly to Europe) comply with GHS (OSHA and REACH). Main concern of relevant authorities is related to small and medium size manufacturers, distributors, importers and in some cases retailers.

Status of the Harmonization in Brazil Brazilian suppliers are looking to the growth of the internal market. Moreover, Brazil exports raw material and not much finished goods. Authorities are concerned about the compliance to current regulatory and environmental provision. Public health is a main concern.