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:
The Ordinance contains two important dates:
Highlights of adopted complementary documents for the conformity assessment requirements are summarized in Table 1.
Item | Document | Title |
|---|---|---|
1 | Inmetro Ordinance No. 200/2021 of April 29, 2021 | Approves the Consolidated General Product Certification Requirements (Requisitos Gerais de Certificação de Produtos, RGCP) |
2 | Law No. 11.256 of 2006 | Regulates the sale of food for infants and young children, as well as related childcare products |
3 | Anvisa Resolution RDC No. 221, 2002 | Approves the technical regulation on pacifiers, nipples, baby bottles and nipple protectors |
4 | Anvisa Resolution RDC No. 81 of 2008 | Technical regulation on goods and imported products for sanitary surveillance properties |
5 | ABNT NBR 5426:1985 | Sampling plans and inspection procedures by attributes |
6 | ABNT NBR 10334:2020 | Pacifiers (soothers) safety – Manufacturing requirements |
Table 1
SGS offers a range of consulting, training, product development, testing, auditing and inspection services to help you demonstrate that your products are safe, high quality, and that they comply with the strict regulations that are enforced by markets around the world. In the end, it’s only trusted because it’s tested. Contact us for more information or visit our website.
For inquiries, please contact:
Dr. Hingwo Tsang
Global Information and Innovation Manager
t: (+852) 2774 7420
Bruno Grigoleto
Manager
t: (+55) 11 2664 9595 ext. 8060
© SGS Group Management SA - 2021 - All rights reserved - SGS is a registered trademark of SGS Group Management SA. This is a publication of SGS, except for 3rd parties’ contents submitted or licensed for use by SGS. SGS neither endorses nor disapproves said 3rd parties contents. This publication is intended to provide technical information and shall not be considered an exhaustive treatment of any subject treated. It is strictly educational and does not replace any legal requirements or applicable regulations. It is not intended to constitute consulting or professional advice. The information contained herein is provided “as is” and SGS does not warrant that it will be error-free or will meet any particular criteria of performance or quality. Do not quote or refer any information herein without SGS’s prior written consent.
