PC&MCB GRA 2023 1ST Q REPORT

Quarterly PC & MCB GRA Results’ Summary

Top Highlights
1) MoCRA (Modification of the US Cosmetic Regulatory Act)
The MoCRA is the most important regulatory reform affecting the Cosmetic Regulatory Framework in the last century in the countries
in which Genomma Lab operates, being the First Significant FD&C Act Reform for Cosmetics Since 1938 in the United States. Notification
of cosmetic products’ portfolio in the US, manufacturing facilities’ registration vis-à-vis FDA, safety substantiation and adverse events
reports to FDA are the shorter-term obligations to be met with the US Board of Health. Labeling requirements and GMP regulation will
follow. Genomma Lab is roughly 80% fit to meet with these new obligations, as a relevant global compliance program has been
implemented since 2016. However, some strong coordinated team work among different functions will be needed to avoid any impact.
Project leader: local US Regulatory Affairs team. / Help needed: cross-functional collaboration and priorities’ alignment
2) PC Industry Associations. Change of Genomma Lab representative at the Board of Directors
Jorge Brake is from now on the new Genomma Lab representative in the BoD of our main Industry Associations in Mexico and in LatAm:
CANIPEC and CASIC. During Q1, Jorge was introduced to the President of both Associations, and he has already started representing the
company, replacing Luciana Santi in her current role at CASIC BoD. He has also been appointed as CANIPEC VP. In June, the CASIC BoD
elections will take place. Jorge will be a candidate for sitting at the steering committee (we hold the Secretary of the Board since 2020,
after 2 periods of Vice-Presidency).
3) Suerox advertising watch out: Implementation of food advertising evaluation/ approval processes by BoH of Mex, Arg and Col;
divergent, unclear criteria which can cause delays in the launch of new Suerox advertising campaigns to be taken into account.

Action Plan Progress

Mexico PC Remediation plan: this program comprises different aspects of product compliance, including labeling and
formula. 137 PC products currently active in the program. Highlights Q1: to 31st March, 97% completed, of which 69% is
implemented on market. Main bottleneck: High MoQ supplies.
PC Emerging Ingredients’ Program: This program aims to proactively replace ingredients that are in the Authorities
restriction pipeline (i.e. future restrictions / bans). 25 ingredients involved, 112 PC products. Highlights Q1: registrations
(filled in/achieved): 59, on-going processes: 80. Main bottleneck: R&D formulation lead times
Suerox regulatory situation across operation countries (registration or in-company assessment when registration is not
a requirement):

Productivity projects and results

SC Facility: First cross functional meeting took place in March. Key projects were identified. Regulatory information sent
to DS for planning.
Trust team MC&B: regulatory initiative to optimize efficiencies, create synergies and build company trust for the MC&B
BU. The cross-functional team started working in Q1, and this year is led by GRA, with active support of Medical, R&D and
Quality. The team provides technical advice, recommendations for problem solving affecting the BU, pro-active
approaches to avoid foreseeable issues, ideas and execution of plans to contribute to the growth of the MC&B business.

Luciana Santi – Jennifer Pérez – Oscar Rodríguez

2023 / 4 / 10