Regulation in Central and South...

Regulation in Central and South America

Michael S. Wenk Director, Product Stewardship and Regulatory Affairs, Americas Kemira Chemicals, Inc

Overview • Common Themes • A Word About Terms… • Argentina • Brazil • Chile • Colombia • Honduras • Mexico • Venezuela • Food contact regulations • Endocrine disruptors

15 October 2014 | Chemical Regulation in Central and South America | Michael S. Wenk | | 2

Common Themes

1. Generally, no formal chemical inventory in place;

2. Generally, no formal pre-notification schemes;

3. Generally, GHS has not been implemented;

4. Many unique, localized regulations exist;

5. Many “twists” on global regulations exist


A Word About Terms… “Pre-Market Notification”: Entity must actively apply for permission prior to manufacture/import can take place

“Registration”: Entity must provide certain information to the authority, but does not receive “permission”

“National Inventory”: A positive list of chemicals which can be manufactured or imported


Argentina


Chemical Regulation in Argentina

• No specific reporting requirements for new chemical substances

• Pre-notification requirements for dangerous substances and preparations (Law No. 26.045

(07 July 2005)

• Regulations for packaging and labelling exist

• Regulations are published in Argentine Official Gazette

• Competent authority is National Administration for Drugs, Food and Medical Technology (ANMAT)


Chemical Regulation in Argentina • Resolution 709/98 (09 July 2008); registration of domestic use chemical products

• National Register for Domestic Use Products w/ 5 year registration period

• Failing to re-register results in immediate product cancellation

• Argentina follows the EU’s Dangerous Substances Directive w/r/t classification, packaging

and labelling



Chemical Regulation in Argentina • Ministry of Economy requires product labels to include:

• Product name • Country of origin • Degree of purity or quality • Net weight

• Primary labelling must be in Spanish, but may contain other languages

SDS in Argentina • Argentina follows ANSI Z400.1 guidance, with Spanish being the preferred language

• This standard is in line with GHS SDS requirements, but Argentina has not formally

adopted GHS

• IRAM 41400 (18 September 2013) - Contenido y orden de las secciones

• Chemical products, safety data sheets. Content and order of sections (Still voluntary - will probably be confirmed by law sometime in 2014)



Brazil

Chemical Regulation in Brazil

• The Brazilian Congress and the Office of the President (along with Ministries and Agencies) has authority for managing chemicals;

• Congress issues Federal chemical management/control laws, but no comprehensive (e.g. REACH) law exists;

• Control laws exist for: • Pesticides • Sanitizers • Explosives • Workplace chemicals

• Only pesticides and sanitizers must be registered before sale



• No Brazilian chemical agency (similar to U.S. EPA, ECHA) exits, so some overlap in regulation occurs;

• Currently, the following Ministries and Agencies cooperate to manage chemicals: • Ministry of Transport (UN dangerous goods enforcement) • Ministry of Labor (workplace chemical enforcement) • Ministry of Health (regulates cosmetics, pharma, sanitizers, etc.) • Ministry of Agriculture (pesticide regulation and enforcement) • Ministry of Defense (chemicals used in manufacture of explosives) • Ministry of Justice (chemicals used in illegal drug production) • Ministry of Industry and Trade (import/export of “others”)



• Brazilian standards organization (ABNT) – developed standard for SDS

• Brazil has implemented GHS (NBR 14.725)

• Ordinance NR 26 (“NR 26”) requires workplace chemicals to be classified according to GHS, but only for physical and health hazards

• NR 26 outlines labelling requirements – must be in Portuguese, and must contain at least:

• Product and manufacturer identity • Pictogram, signal word and hazard statement • Precautionary statement and pictogram


Chemical Regulation in Brazil • Further under NR 26:

• Manufacturer/importer must prepare and share SDS for all chemicals which meet GHS

hazard criteria, or whose use can pose risk to workers

• Must also be in Portuguese

• SDS format and content must follow Annex IV of Purple Book, or ABNT Standard NBR 14.725

• No need to submit classification for approval

• Testing must be done per GLP



• There is NO REGULATION OR GOVERNMENTAL ACTION regarding:

1. Registration and authorization process;

2. National chemical inventory;

3. New chemicals notification process and confidentiality protection;

4. Polymers;

5. Risk assessments carried out by manufacturers or distributors;



Chile

Chemical Regulation in Chile:

• Ministry of Health and Health Services (Ministério de Salud y Servicios Sanitarios) has authority for managing chemicals & waste

• Chemicals: Legislative article is the Sanitary Code (Executive Law Decree No. 725)

• Regulates manufacture, import, distribution, transport, sale and disposal

• Import of “hazardous substances” must obtain clearance from Ministry prior to import


Chemical Regulation in Chile

• No formal registration requirements for importers

• No national inventory of existing substances exists

• No requirement for pre-market notification (new substances)

• Ministry of the Environment (Ministério del Medio Ambiente) has promulgated guidelines for environmental compliance plans and handling self-reported environmental violations

• Similar to U.S. Environmental Protection Agency’s (EPA) “Audit Policy”


Occupational Exposure in Chile

• Decree No. 594/2003 establishes Occupational Exposure Limits (OEL) for caustic, toxic or “narcotic effects” chemicals in the workplace

• Ministry of Labour and Social Security, Ministry of Health share responsibility for workplace health and safety

• OELs based on 48, not 40, hour workweek

• Unique values: • Temporary Permissible Limit (TPL): max value for 14 continuous minutes • Allowable Absolute Limit (AAL): max value for airborne concentrations at any point

during working hours


Chemical Regulation in Chile

• Decree No. 78 (11 September 2010) requires storage and labelling of dangerous chemicals

• Title XIII requires: • Labelling in Spanish • Black lettering on white background (horizontally) • Include, at minimum, information which matches the SDS data • Chemical name • UN number(s) • Name, address, telephone number of manufacturer


SDS in Chile

• Decree 594/2003 – “Regulation of Health Conditions and Basic Environmental Workplaces”

• Norma Chilena No. 2245 (2003) – content and order of sections for SDS & labels

• These requirements parallel ISO 11014-1194 and EU Directive 2001/58/EC;. • Documents must be in Spanish

• GHS training in place June – August 2013

• Website for GHS efforts in Chile: http://www.ghs-chile.cl/


http://www.ghs-chile.cl/


Colombia

Chemical Regulation in Colombia

• Member of Andean Community (Comunidad Andina, or CAN): Bolivia, Colombia, Ecuador, Peru

• Subscribes to CAN legislation, as well as national laws

• No formal national inventory of chemicals exists

• However, National Health Code (Title III of Law 9) allows Ministry of Health to prohibit or restrict product (believed to) posing public health danger

• Code is administered by the National Institute for the Surveillance of Food and Medicines


Chemical Regulation in Colombia

• Ministry of Health, per Article 133 of Law 9, may: • Regulate the classification of dangerous substances

• Law 55/1993 defines what makes a chemical “dangerous”

• Dictates specific packaging, transport methods, labelling and other requirements

• Labels must be “easily understood” by those handling

• Toxic products must display skull and crossbones, the word “envenear” (“poison” in Spanish), use and antidote information


SDS in Colombia

• Law No. 55/1993 – lays out handling requirements • Norma Técnica Colombiana (NTC) 4435 mirrors ANSI Z400.1 guidance

• Must include on the SDS:

• Specific information on identity • Manufacturer • Classification • Risk • Safety precautions & emergency procedures

• Spanish is preferred, but English is also accepted • GHS has not been adopted in Colombia, but is being considered



Honduras

Chemical Regulation in Honduras

• Challenges with accessing Honduran laws: • La Gaceta: Diario Oficial de la Republica de Honduras (not electronic) • Many laws have been amended over time, but no official consolidation

• Honduras has chemical control regulations in place • However, does not have formal system in place to monitor controlled substances • Also does not have automated management system

• General Directorate for Health Regulation (part of Department for Health Control of Goods and Services) is competent authority


Chemical Regulation in Honduras

• No specific format for chemical product labels • As long as hazard pictograms, the word “WARNING” and hazard statements appear

together

• The “General Rules of Preventative Measures of Occupational Accidents and Diseases” (2004) regulates chemical labeling

• Label must contain, at minimum: • Warning phrases • “Indication of danger” • Precautionary statements and pictograms • Product identification (name of substance or preparation) • Supplier identification (name, address, telephone no. of manufacturer)


SDS in Honduras

• Any company handling chemicals must have an SDS for the hazardous substance/preparation

• Honduras’ requirements for SDS mirror ANSI Z400.1

• Honduras has implemented GHS



Mexico

Chemical Regulation in Mexico

• Mexican Chemical Inventory (Inventario Nacional de Sustancias Químicas - INSQ)

• At the moment, unclear what the Inventario “means”; – Are listed chemicals exempt from notification? – What is the notification process (if there is one)? – What are the exemptions (if any), etc.?

• Competent authority is the Instituto Nacional de Ecología y Cambio Climático (INECC)

• Some sources (e.g. Ariel) are listing the Inventory – value?

• Per INECC: “the inventory is not a compulsory regulation” – Largely because lacks legal framework for reporting, enforcement, etc.



Venezuela

Chemical Regulation in Venezuela

• Law on Dangerous Substances, Materials and Waste (03 September 2001, amended 13 November 2011)

• 1st regulation on hazardous substances • Specific authority in Articles 65 and 66

• Purpose is to regulate the generation, use, collection, storage, transportation, treatment and disposal of hazardous substances, materials and waste, as well as any other operation that involves these products.

• Law also regulates substances and materials that are typically used for agricultural, industrial, scientific research, education and production purposes.


Chemical Regulation in Venezuela • Following are required:

1. Proof of registration (from Dir. Gen. of Envt’l Quality) 2. A report of the activity 3. A list of substances, materials or haz waste, including:

1. For hazardous substances: SDS 2. For materials and haz waste:

1. Phys/chem characteristics • Must be performed by lab approved by MARN (Environment

and Natural Resources Ministry) 4. Periodic training for those who handle, store or transport 5. Risk analysis for activities involved in managing 6. Emergency and Contingency Plans

• Must include a system for 24hr response


Chemical Regulation in Venezuela • Decree 2635, “Norms on the Control and Recovery of Hazardous Materials and

Handling of Hazardous Waste” (1998)

• “Requirements for Registration and Authorization of Operators of Dangerous Substances, Materials and Waste” (2003)

• “Organic Law Against Illicit Trafficking and Consumption of Narcotic and Psychotropic Substances” • Articles 125 and 131-137 require registration of “person or entity involved in…any

transaction where controlled chemicals are involved”


SDS in Venezuela

• COVENIN (Comision Venezolana de Normas Industrial) Standard 3059 • Establishes SDS requirement • “Hazardous Materials: Safety Data Sheet Materials” (Materiales Peligrosos: Hoja de

Datos de Seguridad de los Materiales) • Generally follows ISO 11014-1: 1994 and EU Directive 91/155/EEC

• No intention at present to implement GHS

• However, has asked for assistance from UNITAR-ILO for above


Elsewhere

• Ecuador: • Ministry of Environment has implemented SDS guidelines (INEN 2266:2013) as of 11

November 2013 • Prior to then, companies could use UN “Purple Book” • Post 11 November 2013, must use Annex B of INEN 2266:2013 (based on First

Revision of UN GHS!), but use latest (Fifth Edition) for areas of SDS not addressed by INEN 2266:2013

• Brazil (Sao Paulo): • Law Proposal No. 585/2013 would require products to display clear information on

packaging about life cycle

• Appears to be targeted for electronic equipment, but Proposal does not restrict the scope


A word about food contact legislation in MERCOSUR

• MERCOSUR: South American trading bloc • Argentina, Brazil, Paraguay, Uruguay and Venezuela

• GMC Resolution No. 3/92 established food safety (incl. packaging) regulations

• Requires such materials be:

• Manufactured per GMPs; • Of suitable purity; • Not transfer any harmful/ toxic agents from the packaging; • Not cause unacceptable changes in food composition, taste or odor • Similar in large part to U.S. FDA; not as much to BfR or GB 9685


A word about food contact legislation in MERCOSUR

• GMC Resolution No. 02/12 • Applies to specific categories of food-contact materials, such as plastics and

adhesives. • Positive list

• If a substance is cleared in the EU or U.S., it is reasonable to expect it to be adopted with

similar limitations

• However, submission review must take place by MERCOSUR


Additionally

• Certain Central/South American countries are beginning to implement their own version(s) of food contact legislation

• Notably – Ecuador

• “Materials and Articles in Contact with Foodstuffs”. • Similar in principle to the U.S. Food and Drug Administration’s 21 Code of Federal

Regulations (CFR) 176.170 (“Components of paper and paperboard in contact with aqueous and fatty foods”)

• NTE INEN 1186-3 et seq., Materiales y artículos en contacto con productos alimenticios (“Materials and articles in contact with food” – test methods) - test methods to be used for migration into aqueous food simulants


Endocrine Disruptors

• 4th Latin American and Caribbean SAICM regional meeting (Mexico City, 19-22 August 2013): http://www.saicm.org/index.php?option=com_content&view=article&id=478&catid=101

• Discussed importance of developing endocrine disruptor regulations specific to the region

• Group asked the UN’s Environment Program (UNEP) and the World Health Organization (WHO) to:

• Provide a list of key endocrine disruptors • Review local legislation and identify gaps where laws should be created • Identify best practices globally to use as models


http://www.saicm.org/index.php?option=com_content&view=article&id=478&catid=101

Thank you

to

Chemical Watch


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