Regulations of MAGNESIUM GLYCINATE

How does the regulatory treatment of Magnesium bisglycinate differ by market or product category?

Regulatory treatment differs by market and product category. In the EU, Magnesium bisglycinate (CAS 14783-68-7) is listed in the ECHA C&L Inventory with aggregated GHS notifications, indicating hazard communication obligations, and falls under the EFSA legal basis of Regulation (EC) No 178/2002, which applies to food and feed safety. In cosmetics, it is an active ingredient under the INCI name MAGNESIUM GLYCINATE with the function of buffering, and no restrictions or maximum concentration limits are specified. This suggests that for cosmetic use, it is permitted without specific concentration caps, whereas for food or feed, general EU food law applies.

EFSA Legal Basis

Regulation (EC) No 178/2002 (amended)

Status Regulation (EC)

Regulation (EC) No 178/2002 (amended)

Which conditions, limits, and use contexts most affect a compliance assessment for Magnesium bisglycinate?

The most impactful conditions and limits for compliance are the absence of specific exposure limits and GHS classifications in the available data, and the lack of cosmetic restrictions or maximum concentrations. For EU cosmetics, the ingredient is listed as active with no annex restrictions, conditions, or concentration caps, meaning it can be used as a buffering agent without category-specific limits. However, the ECHA C&L notifications imply that hazard classification and labeling may be required based on aggregated GHS data. For food applications, the EFSA legal basis under Regulation (EC) No 178/2002 sets general safety requirements but no specific quantitative limits are provided.

What should be in place before a product containing Magnesium bisglycinate is assessed for launch?

Before launch, a compliance assessment should confirm the product category and applicable regulatory framework. For EU cosmetics, verify that the ingredient is used within its listed function (buffering) and that no restrictions apply, as none are currently specified. For food or feed, ensure compliance with Regulation (EC) No 178/2002, which requires that the product be safe and not misleading. Additionally, review the aggregated ECHA C&L notifications to determine if any GHS hazard classifications apply, which would affect labeling and safety data sheets. Documentation should include the ingredient's identity (CAS, EC number) and any relevant safety data.

Where does the available regulatory position stop short of supporting a decision on Magnesium bisglycinate?

The available regulatory position is insufficient to support a full launch decision because it lacks quantitative exposure limits, GHS classifications, and any specific use conditions or restrictions. While the EU C&L inventory indicates that companies have submitted hazard notifications, the actual classifications are not provided. Similarly, the EFSA legal basis is a general framework, not a specific approval for this ingredient. For cosmetics, the absence of restrictions is informative but does not confirm safety for all product types or concentrations. Therefore, a decision cannot be made solely on this evidence; additional regulatory and safety data are needed.

Which recent regulatory changes or effective dates are material for Magnesium bisglycinate?

No recent regulatory changes or effective dates are provided in the evidence. The only regulatory references are the ECHA C&L notifications and the EFSA legal basis under Regulation (EC) No 178/2002, which is an amended regulation but no specific amendment date is given. For cosmetics, the ingredient is listed as active with an official journal reference, but no recent updates or effective dates are mentioned. Therefore, there is no material regulatory change to consider in the current assessment.

Regulations of Magnesium Bisglycinate