Brazil Approved Amendments to Regulations for Plastic Food Contact Materials
The Brazilian Health Regulatory Agency (Anvisa) has published Resolution RDC No. 326 of 2019 to amend certain regulations for plastic food contact materials, and revoke Resolution RDC No. 17 of 2008 regarding the positive list of additives for such materials. Products shall comply with the new provisions by 1 June 2020.
A. Incorporating Mercosur’s GMC Resolution on additives for food contact plastic materials and polymeric coatings
Mercosur’s GMC Resolution No. 39/2019 shall be adopted. Its details can be referred to following Regulatory Update:
http://www.sjbchjg.com/listdata/100539.html
B. Changes to national regulations
1. Resolution No. 105 of 1999
Dyes and pigments used in plastic food contact articles and packaging shall comply with Resolution RDC No. 52 of 2010.
2. Resolution RDC No. 52 of 2010
The change in specific migration limits of elements in dyes and printed materials used in plastic food contact articles and packaging are as follows:
|
Element
|
Old Specific Migration Limit (SML)
|
New SML
|
|
Boron (B)
|
0.5 mg/kg
|
6 mg/kg
|
|
Zinc (Zn)
|
25 mg/kg
|
5 mg/kg
|
3. Resolution RDC No. 56 of 2012
Substances that are not included in the positive list of additives but are still authorized for use in food contact plastic materials and polymeric coatings are:
a) Salts, including double salts and acid salts, of ammonia, calcium, magnesium, potassium and sodium of authorized acids, phenols or alcohols
b) Salts, including double salts and acid salts of aluminium, barium, cobalt, copper, iron, lithium, manganese and zinc of authorized acids, phenols or alcohols with the following group specific migration limits:
|
Element
|
Group Specific Migration Limit
|
|
Aluminium
|
1 mg/kg
|
|
Barium
|
1 mg/kg
|
|
Cobalt
|
0.05 mg/kg
|
|
Copper
|
5 mg/kg
|
|
Iron
|
48 mg/kg
|
|
Lithium
|
0.6 mg/kg
|
|
Manganese
|
0.6 mg/kg
|
|
Nickel
|
0.02 mg/kg
|
|
Zinc
|
5 mg/kg
|
c) Substances mentioned in Note (23) and (24), Part IV of the Annex of Resolution RDC No. 56 of 2012
Remark: When acids, phenols or alcohols are listed followed by the word "salts", only the salts of the cations mentioned in Points a) and b) are authorized. The corresponding free acids, phenols or alcohols are not permitted.
Note:
Resolution No. 105/1999 Technical regulation on general provisions for plastic packaging and equipment in contact with food.
Resolution RDC No. 52/2010 Colorants in plastic packaging and equipment intended to be in contact with food.
Resolution RDC No. 56/2012 Positive list of monomers, other initiators and polymers authorized for the preparation of plastic packaging and equipment in contact with food.
Resolution RDC No. 17/2008 Technical regulation on the positive list of additives for plastic materials for the preparation of packaging and equipment in contact with food.
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