Mercosur Reach Regulation For Various Sectors

Regulation Framework

The basic Framework in the Mercosur countries closely resembles the Food Contact Material and Articles regulations to that of the European Union and to some measures of the US-FDA. MERCOSUR's executive body is the Common Market Group. It is composed of five titular members and five alternate members per country, who are selected by their respective governments and must include representatives from the Ministries of Foreign Affairs, Economy (or equivalent), and Central Banks.

Overview

• Containers or articles which are intended to come in contact with the food particles must be produced as per the GMP i.e. the good manufacturing practices; so as to avoid the migration or transfer of the harmful contaminants into the food under normal conditions. Following principles are supposed to be followed for FCM:
  • Materials must be in the positive lists
  • Use restrictions to be declared (if needed for specific materials)
  • They must adhere to purity standards that are appropriate for their intended purpose.
  • They must adhere to the overall migration restriction as well as the specific migration limits set for individual components or groups of components.
  • Under acceptable conditions, the containers must have closures or closure devices that prohibit involuntary container opening. Except in explicitly designated instances, systems or procedures that make them inviolable or show proof of intentional opening will not be necessary.
  • All containers and materials that will come into contact with food in the trading process between States parties must be approved by the competent authority of the State Party of provenance or origin and endorsed by a certificate from that country. compliance with both the general and special MERCOSUR Regulations.

Specific Measures to regulations

Plastic Containers and equipments

• This Resolution applies to packaging and equipment constructed or covered with plastic material for domestic use, including coatings and accessories intended to come into contact with food, mineral and table water, and raw materials for food.

Colourants & pigments

• As per GMC:56/92 it is declared that in order for the colour or the pigment to come in contact with the container/equipment; following requirements must be met: -
  • No migration should occur.

Glass & Ceramics

• Only the following types of glass may be used in containers and equipment that come into contact with food: - Borosilicate glass:
  • Allowed for the production of containers and equipment for any form of food contact, including sterilisation and cooking in industrial and residential ovens.

Wax & Paraffins

Resolution GMC 20/00 technical regulation on food contact paraffin waxes and applies to synthetic food contact paraffins, petroleum waxes, and polyethylene waxes, as well as products based on these substances, which are used in coatings for packages and articles intended to come into contact with foodstuffs.

Metallic Materials- Regulations

• GMC 46/06 i.e. Technical regulation for metallic packages and articles for food contact.
• This rule applies to packages, coatings, and products made of coated or non-coated metallic materials that are meant to come into contact with food particles while their production, shipping, storage.
• The article must not transfer harmful contaminants into the food thereby changing the composition of the food present.
• This Resolution establishes a positive list of metallic raw materials that are prohibited, including tinplate, chromium-coated steel, aluminium, and its alloys, among others.

Safety Assessments

• The total number of samples to be tested is the number of samples that must be sufficient to produce a stimulant liquid volume of at least 250 ml.
• Preparation of samples
  • The items that will be evaluated must be clean and grease-free. They must be washed in a diluted and lukewarm solution of a commercial detergent, then rinsed with running water and distilled water at least twice, or immersed in distilled water for at least 30 minutes at rest.
• A test with no results Blank tests will be performed in all circumstances, using the same amount of distilled water as the test.
• Method of extraction:
  • Fill each of the objects with 90 percent of their capacity with distilled water and keep track of the volume utilised.
  • Cover the samples with a Petri dish or a watch glass. These materials must have been autoclaved for 1 hour at 121^oC +- 10^oC at least three times.
  • In the autoclave, place the samples under the following conditions:
  • 20 minutes to reach 100°C - 10 minutes to allow steam to freely flow
  • It takes 2 minutes to reach 121°C.
  • 30 minutes at 121°C - 42 minutes + 4 minutes for cooling
  • Air cooling for 15 minutes Remove the samples from the autoclave and set them in an 80°C water bath, chilling for 10-20 minutes with running water until they reach room temperature.

How can GPC help you?

• Identification of compliance requirements under various guidelines including all data requirements.​ 

• Data gap analysis and pre-assessment support​ 

• Technical documentation support​ 

• Pre and post submission support and technical liaison with authorities.