RIO DE JANEIRO—Humane Society International is thrilled to announce that safety assessment of pet-free school supplies is now possible in Brazil. Previously, rats and rabbits were commonly used to test paints, glues and other school supplies. HSI has worked with Brazilian stakeholders to change safety requirements for school supplies, avoiding the use of many animals.
Although several non-animal methods have been accepted in Brazil since 2014, due to the lack of clarity, animals are still commonly used. The non-animal evaluation of school supplies first required modifying the Brazilian National Association for Standardization (ABNT) standard for the safety of school items to allow the evaluation of the product based on existing information on its ingredients. Another important change is the requirement that animals are only used as a last resort and only when technical justifications are present. These unprecedented changes were codified in ABNT NBR 15236:2021, released September 9.
The second change required was for the registration authority to refer to this new standard, which was published on October 8 in Inmetro order number 423. This makes ABNT 15236:2021 the mandatory requirement for the assessment of toxicological safety and compliance of school supplies in Brazil. .
These regulatory changes are the result of a joint effort and HSI appreciates the discussions involving the various stakeholders and the strong support provided by the National Council for the Control of Animal Experimentation (CONCEA).
“These seemingly simple changes ensure the safety of children while avoiding the unwarranted use of many animals in the safety assessment of school supplies in Brazil,” said Dr. Bianca Marigliani, HSI Science Advisor. “These changes also set a precedent for the kind of regulatory clarity needed to finally implement non-animal methods in chemical safety assessment in Brazil and bring us closer to regulatory harmonization with other countries.”
Media contact: Bianca Marigliani: email@example.com; +55 11 97635-6068
According to Brazilian regulations, all school supplies containing more than 3 grams of paints, glues, gouaches, watercolors and powdered materials per unit of use must have their safety confirmed with regard to acute oral toxicity. People who are sensitive to skin contact should also have their safety confirmed in case of skin irritation. According to the previous version of ABNT 15236 (Amendment 1, published May 2020), acute oral toxicity and skin irritation could be assessed by live Where in vitro methods, meaning labs were free to choose between testing on live animals or using alternative methods, in these cases, cell cultures. Also, in Brazil, safety testing has traditionally been done on finished products, which is expensive, time-consuming and has significant limitations, relying mostly on animal testing.
HSI Brazil’s Research and Toxicology Department has identified that Brazilian Standard ABNT 15236:2020 is in disagreement with:
- the principle of the three Rs, which means reduction, refinement and replacement of animal use;
- the Environmental Crimes Act (Law number 605/1998), which makes it a crime to use live animals for scientific purposes when there are alternatives; and
- CONCEA Normative Resolution Number 18, which recognized alternative methods for different endpoints, including an alternative (non-animal) method for skin irritation, and with a five-year time limit for mandatory replacement of the animal method, has ended in September 2019.
Recognizing the possibility of unwarranted and abusive use of animals for conformity assessment of school supplies, HSI successfully engaged CONCEA and ABNT in the discussion to modify the ABNT 15236 standard. ABNT organized a series online meetings with HSI and CONCEA members, laboratory and school supply industry representatives, and other stakeholders to discuss HSI’s suggestions to modify ABNT’s requirements for safety of school supplies. After two rounds of public consultation, HSI’s suggestions were accepted and the ABNT 15236:2021 standard was published on September 9, 2021.
The main changes per endpoint are as follows:
- for both acute oral toxicity and dermal irritation, ingredient-based safety assessment is the recommended strategy.
- for acute oral toxicity, in vitro the methods can be used if it is not possible to perform an ingredient-based safety assessment, and live methods are only allowed as a last resort and when there is a technical justification (e.g. incompatibility of the sample with the in vitro test).
- for skin irritations, an Integrated Testing and Assessment (IATA) approach should be followed, if further testing is required, in vitro methods can be used, and live methods are only permitted as a last resort and when there is a technical justification.
ABNT 15236:2021 is now cited by the consolidated version of Inmetro Ordinance number 423, which determines the requirements for the conformity assessment of school supplies. This makes ABNT 15236:2021 the mandatory requirement for toxicological safety assessment and compliance of school supplies in Brazil. Changes to ABNT 15236 keep children safe while ensuring the use of animals as the very last resort, which may prevent the unwarranted use of many animals in the safety evaluation of school supplies.