Brazil’s ordinance on baby bottles and teats entered into force on June 1, 2021. A recent amendment made editorial changes to the list of complementary documents for conformity assessment requirements.
In May 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 Ordinance No. 216 of May 5, 2021 (Portaria No. 216, de 5 de Maio de 2021) approving the consolidated conformity assessment requirements for baby bottles and teats (the Ordinance).
The Ordinance contains, inter alia, several important provisions. It:
- Establishes the consolidated legislation for baby bottles and teats 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 testing) or 5 for conformity assessment requirements – the Certificate of Conformity (CoC) for Model 5 is valid for three years
- Requires certificates that have been issued to be evaluated against ‘the Ordinance’ in the next evaluation
The Ordinance entered into force in June 2021.
Since its publication, an amendment published on August 24, 2021 has made several editorial changes to the list of complementary documents for the conformity assessment requirements (see Table 1 below).
Highlights of adopted complementary documents for the conformity assessment requirements are summarized in Table 1.
Law No. 11.265 of January 3, 2006
Regulates the sale of food for infants and children in early childhood and also related childcare products
Resolution RDC No. 56 of November 16, 2012, or substitute
Provides for the positive list of monomers, other starting substances and polymers authorized for the manufacture of plastic packaging and equipment in contact with food, the ban on the use of Bisphenol A in baby bottles for feeding infants and other measures
Resolution RDC No. 123 of June 19, 2001, or substitute
Technical regulation on packaging and elastomeric equipment in contact with food
Resolution RDC No. 51 of November 26, 2010, or substitute
Provides for the regulation of migration in materials, packaging and plastic equipment intended to come into contact with food
Resolution RDC No. 52 of November 26, 2010, or substitute
Provides for the regulation of dyes in plastic packaging and equipment intended to come into contact with food
Resolution RDC No. 17 of March 17, 2008, or substitute
Provides for the positive list of additives for plastic materials intended for the manufacture of packaging and equipment in contact with food
Resolution RDC No. 221 of August 5, 2002, or substitute
Provides for the regulation of pacifiers, teats, baby bottles and teat protectors
Anvisa Resolution No. 105 of May 19, 1999, or substitutes
Provides for the regulation of general provisions for plastic packaging and equipment in contact with food
Ordinance No. 27 of March 19, 1996
Provides for the regulation of glass and ceramic packaging in contact with food
Inmetro Ordinance in force
General product certification requirements (Requisitos gerais de certificação de produtos – RGCP)
ABNT NBR 13793:2012
Safety of baby bottles and bottle teats
ABNT NBR 5426:1989
Sampling plans and procedures in inspection by attributes
On the same day as publication of the amendment to revise the Ordinance on baby bottles and teats, Brazil’s Ministry of Economy/Inmetro also issued a similar (editorial) amendment to Inmetro Ordinance No. 301 of July 12, 2021 for pacifiers by inserting ‘or substitute’ or ‘or substitutes’ to Anvisa Resolution RDC Nos. 221 of 2002 and 81 of 2008 to the list of adopted complementary documents for conformity assessment requirements (SafeGuardS 108/21).
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