50th Amendment to the IFRA Code of Practice
On June 30, IFRA announced the notification of the 50th Amendment to the IFRA Standards. The Standards form the basis for the globally accepted and recognized risk management system for the safe use of fragrance ingredients and are part of the IFRA Code of Practice. The amendment introduced one update to the Standards and one new prohibited substance – Mintlacton.
Marta Pinto

Marta Pinto

Regulatory Affairs Associate

FRAGRANCES, IFRA CODE OF PRACTICE AND THE NEW AMENDMENT

Fragrances are complex mixtures of aromatic substances of natural and/or synthetic origin that are added to cosmetics and personal care products to impart a pleasant and distinctive odour, mask the inherent odour of some ingredients and/or enhance the user experience of the product. However, some fragrance ingredients may have the potential to cause allergic contact skin reactions (like dermal sensitization).

It is possible to analyse these substances using a methodology called Quantitative Risk Assessment (QRA) to determine safe use levels of fragrance ingredients in a variety of consumer product types. Organizations such as the International Fragrance Association (IFRA) and the Research Institute for Fragrance Materials (RIFM) use QRA to conduct safety assessments. The International Fragrance Association (IFRA) was founded in 1973 and represents the interests of the fragrance industry worldwide. The IFRA Code of Practice is essentially the “global fragrance industry’s commitment to promoting the safe use of fragrance for everyone’s enjoyment”. Fragrance compliance means following the rules of the IFRA Code of Practice and the IFRA Standards (see previous post).

IFRA Code of Practice includes the manufacture and handling of all fragrance materials, for all types of applications. IFRA Standards form the basis for the globally accepted and recognized risk management system for the safe use of fragrance ingredients and are part of the IFRA Code of Practice. These Standards limit or ban the usage of certain fragrance materials. IFRA gathers information regarding the safety of individual fragrance ingredients and reviews that information to determine their safety under expected conditions of product use. The conclusions of the IFRA safety reviews are published in the IFRA Code of Practice which provides critical guidance to fragrance formulators and cosmetic products manufacturers. New scientific developments about analysed substances often justify amendments to the Code and Standards.

On June 30 this year (2021), the notification of the 50th amendment to the IFRA Standards was issued. According to the notification, there is only one update to the Standards and one new prohibited substance (Mintlacton – CAS No. 13341-72-5). All other elements of the 49th Amendment addressing fragrance materials remain unchanged and in place. Timelines for implementation of the prohibition of use of Mintlacton were set as follows:

  • For new creations – 2 months after the date of the notification letter;
  • For existing creations – 13 months after the date of the notification letter.

The timelines set only apply to the supply of the fragrance mixtures, not to finished products.

Fragrance manufacturers and cosmetic companies have the responsibility to ensure that the fragrances used are safe and compliant with the IFRA Code of Practice and Standards. If you need further information or support on this subject, feel free to contact us at info@criticalcatalyst.com.

References:

  1. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
  2. The International Fragrance Association (IFRA) – Notification of the 50th Amendment to the IFRA Standards. June 30, 2021.  
  3. The International Fragrance Association (IFRA) – Guidance for the use of IFRA Standards, 2019

further
reading

cosmetic products

The Responsible Person in the EU

Only cosmetic products for which a Responsible Person is designated in the European Union can be placed on the EU market. The Responsible Person must ensure full compliance with the European Cosmetic Regulation.

Read More »
cosmetic products

SCCS Preliminary Opinion on Genistein and Daidzein

The European Commission Scientific Committee on Consumer Safety (SCCS) has published its preliminary opinion on the use of Genistein and Daidzein in cosmetic products. The deadline for comments was set at 14 March 2022.

Read More »
cosmetic products

The Cosmetic Products Notification Portal (CPNP)

Only cosmetic products for which a legal or natural person is designated within the EU as a “Responsible Person” can be placed on the European Union (EU) market. Before placing a cosmetic product on the EU market, the RP must notify it in the Cosmetic Products Notification Portal (CPNP).

Read More »
cosmetic products

French Anti-Waste Law

The Loi relative à la lute contre le gaspillage et a l’économie circulaire (Anti-Waste for a circular economy) has come officially into force in France in 2020. Since the beginning of this year, some requirements of the law became mandatory, like the Triman logo. The law provides for a ban on all single-use plastics by 2040.

Read More »
cosmetic products

SCCS Preliminary Opinion on 4-MBC

In 2019, the European Commission set out two lists of ingredients suspected of having endocrine disrupting properties. As 4-MBC (UV-filter) was included in the higher priority group, the European Commission asked the SCCS to carry out a safety assessment on this ingredient. The preliminary version of the requested opinion was published.

Read More »
cosmetic products

SCCS Revision of the Opinion on Vitamin A

Vitamin A is not currently included in the Annexes of the European Cosmetics Regulation (Regulation (EC) No 1223/2009). The SCCS published the preliminary version of its revision of the scientific opinion on Vitamin A (retinol, retinyl palmitate and retinyl acetate). The deadline for comments was set at 7 February.

Read More »
medical devices

Person Responsible for Regulatory Compliance (PPRC) under MDR & IVDR

The EU Medical Device Regulation (EU MDR) and the EU In Vitro Diagnostic Device Regulation (EU IVDR) require all Manufacturers and Authorized Representatives to have a designated employee in their company who is responsible for regulatory compliance with the applicable MDR or IVDR requirements, the Person Responsible for Regulatory Compliance (PRRC).

Read More »