has three main documents that together establish
the rules for chemical industry in the country:
Technical Regulation 078 on transport,
storage, and management of hazardous materials
Acuerdo Ministerial 099 on instructions for the registration of
hazardous chemical substances and environmental obligations
Decreto 752/2019 that states the creation of a chemical
inventory and a chemical registry
Additionally, Ecuador is
part of the Andean Community, which indicates that the communal regulation for
chemical pesticides for agriculture is in place (Resolución 2.075/2019).
Ecuador's National Agency for Health Regulation, Control, and Surveillance (ARCSA) has invited public feedback on a comprehensive proposal to revise labeling requirements for pesticides meant for domestic, industrial, and public health use. The move, which aims to enhance transparency and safety standards, has been put forth in a notification to the World Trade Organization (WTO) dated September 19, 2023.
The proposed amendments to the existing resolution (ARCSA-DE-2021-004-AKGR) concerning registration and labeling stipulations for these pesticides seek to provide more clarity and bring about essential updates to labeling provisions. Notably, these changes aim to redefine the scope of pesticides intended for domestic use, now encompassing "products expressly authorized for use to prevent, destroy, control, or combat pests in the home," including those applied to wood.
One notable aspect that will remain unchanged is the requirement for sanitary certificates, often referred to as health notifications. These certificates will continue to be valid for a duration of five years. Companies will be obligated to apply for re-registration at least 90 days before the expiry of their product's certificate. Failure to adhere to this deadline would necessitate treating the product as new, requiring re-registration. It is important to note that the proposal does not alter certificate or registration prerequisites.
Once the proposal receives approval, it will come into effect immediately upon publication in Ecuador's Official Registry. Stakeholders and interested parties have until October 31, 2023, to submit their comments on the proposed changes.
Key Labelling Changes
One of the pivotal aspects of the proposal is the overhaul of labeling requirements. Under the revised guidelines, pesticide labels would be mandated to include the following information:
Active Ingredients: Labels must specify active ingredients by both their chemical and common names, referencing the International Union of Pure and Applied Chemistry (IUPAC) standards and Ecuadorian technical regulations.
Acute Toxicity: Pesticides will be categorized into four acute toxicity classes, providing consumers with a clear understanding of their potential harm:
Specific Phrases: Specific phrases relevant to the product's formulation will also be mandated on labels.
In cases where active ingredients are not listed in either the IUPAC or Ecuadorian approved sources, those conforming to the International Organization for Standardization (ISO) guidelines applicable to pesticides will be considered acceptable.
Another significant requirement will be that products must be packaged with labeling and information sheets that are resilient to normal wear and tear, including transportation and storage.
These proposed changes reflect ARCSA's commitment to enhancing the safety and transparency of pesticide usage in Ecuador and ensuring that consumers have access to clear and essential information about the products they use.
As the deadline for public comments approaches on October 31, stakeholders are encouraged to participate actively in the process to help shape the future of pesticide regulation in Ecuador. The potential benefits include improved safety, more informed consumers, and a more sustainable approach to pest control in both domestic and industrial settings.
Ecuador has recently released a draft regulation for public scrutiny, outlining the procedures governing the issuance of toxicological evaluation reports, modifications to existing reports, and the alignment of labels with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) for agricultural pesticides.
The proposed changes regarding GHS-compliant labeling have far-reaching implications, as they will affect all registered chemical-based agricultural pesticides in the country. According to the draft, applicants seeking approval for their products will be required to pay a stipulated fee and furnish the specified information for evaluation.
This draft regulation is currently open for public input and feedback, providing a crucial opportunity for stakeholders and concerned citizens to contribute their insights. The public comment period spans a duration of sixty days, commencing from August 30th. Your input during this period can play a significant role in shaping the final regulations governing toxicological evaluations and labeling practices for agricultural pesticides in Ecuador.
Link to the draft in Spanish: 23_12073_00_s.pdf (wto.org)
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