Brazil has published an ordinance detailing the consolidated conformity assessment requirements and conformity identification seal for pacifiers. The ordinance entered into force on August 2, 2021.
On July 16, 2021, Brazil’s Ministry of Economy/National Institute of Metrology, Quality and Technology (Ministério da Economia/Instituto Nacional de Metrologia, Qualidade e Tecnologia, Inmetro) published Inmetro Ordinance No. 301 of July 12, 2021 (Portaria No. 301, de 12 de Julho de 2021) approving the consolidated conformity assessment requirements for pacifiers (‘the Ordinance’).
The ordinance contains, inter alia, several important provisions. It:
- Establishes the consolidated legislation for pacifiers in the form of conformity assessment requirements (Annex I) and specifications for the Conformity Identification Seal (Annex II)
- Requires conformity assessments to be carried out by a Product Certification Body (Organismo de Certificação de Produto, OCP) that is established in Brazil and accredited by Inmetro
- Requires suppliers to choose Certification Model 1b (batch test) or 5 for conformity assessment requirements – the Certificate of Conformity (CoC) for Model 5 is valid for four years
- Requires certificates that have been issued to be evaluated against ‘the Ordinance’ in the next evaluation – the requirements related to the validity of the certificate and the timing of maintenance assessments (Annex I to the Ordinance) will apply to certificates already issued by consideration of their issue date
The Ordinance contains two important dates:
- August 2, 2021, for date of entry into force
- December 31, 2021, for pacifier suppliers to adapt the layout of the Conformity Identification Seal (Annex II)
Highlights of adopted complementary documents for the conformity assessment requirements are summarized in Table 1.
Inmetro Ordinance No. 200/2021 of April 29, 2021
Approves the Consolidated General Product Certification Requirements (Requisitos Gerais de Certificação de Produtos, RGCP)
Law No. 11.256 of 2006
Regulates the sale of food for infants and young children, as well as related childcare products
Anvisa Resolution RDC No. 221, 2002
Approves the technical regulation on pacifiers, nipples, baby bottles and nipple protectors
Anvisa Resolution RDC No. 81 of 2008
Technical regulation on goods and imported products for sanitary surveillance properties
ABNT NBR 5426:1985
Sampling plans and inspection procedures by attributes
ABNT NBR 10334:2020
Pacifiers (soothers) safety – Manufacturing requirements
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