Regulatory Affairs & Health Claims

Makrolife Biotech supports you with health claim validation, labeling, and regulatory compliance for cosmetics, supplements, and pharmaceuticals. Our team ensures your product appears on the market with legally compliant and scientifically supported claims – aligned with EFSA and FDA guidelines.

Do you need support with legal matters regarding health claims and product approvals?

Our legal team is here to help:

E-Mail: info@Makrolife-Biotech.com

Tel:     +49 176 92 67 888 6

What Are Health Claims – And Why Are They Important?

Health claims are statements about health benefits, used on supplements or cosmetics to communicate their positive effect on the body or functions. In the EU, Regulation (EC) No. 1924/2006 governs which claims are permitted – all claims must be scientifically reviewed and approved by EFSA.

Cosmetic products also fall under Regulation (EC) No. 1223/2009, requiring all claims to be substantiated and clearly formulated.
Makrolife Biotech helps you create legally secure, scientifically valid health claims, reducing regulatory risk while strengthening your brand’s credibility.

What Must Be Considered for Health Claims?

Relevant Guidelines

Scientific Evidence

• Every claim must be supported by valid data such as in-vitro efficacy studies or EFSA Health Claims.



Consumer Clarity

• Claims must be clear and understandable without technical jargon or misleading promises.



Legal Approval

• Claims must comply with EFSA standards per Regulation (EC) No. 1924/2006.



No Misleading Statements

• Product benefits must not be exaggerated.
  Makrolife Biotech ensures that your claims meet all regulatory and scientific requirements – for trustworthy and compliant product positioning.

Wolfgang Steiner

"Makrolife Biotech develops, analyzes, markets, and supports the successful positioning of your product and brand. We ensure legally compliant health claims and guarantee the scientific validity and effectiveness of your products – for long-term market success. An outstanding service, especially when everything comes from a single source and we have one reliable point of contact."

CEO, Aquapharma