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point 1
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Understanding EU Cosmetic Regulations
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Placing cosmetic products on the European market goes beyond a simple export activity.
For many global cosmetic brands, the EU is the first market where regulatory
requirements are reviewed during product planning. This is because compliance with EU
standards is widely recognized as facilitating smoother entry into other markets.
Conversely, products that are not adequately prepared for EU requirements are likely to
encounter delays in placing the product on the market due to unforeseen ingredient
issues, labeling non-compliance, or insufficient documentation.
Cosmetic products in the EU are regulated under Regulation (EC) No 1223/2009. This
regulation goes beyond the restriction of specific ingredients; it encompasses product
safety assessment, the designation of a Responsible Person (RP) , labeling requirements,
and marketing claims within a single regulatory system.
As all 27 member states apply the same core legal framework, compliance enables
distribution across the entire EU market. However, practical differences remain
in language requirements, administrative procedures, and market surveillance, making
country-specific strategies necessary.
Notably, the EU does not operate a pre-market approval system. Instead, it adopts a
notification-based framework in which full responsibility lies with the company upon
market placement. In this sense, the EU market is defined less by strictness and more by
accountability and transparency.
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point 2
Core Principles of EU Regulation
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At the core of EU regulation lie consumer protection and the precautionary principle.
Rather than responding after risks are conclusively proven, the system proactively
manages potential hazards at an early stage.
1. Systematic Ingredient Management
The EU does not simply classify cosmetic ingredients as permitted or prohibited.
Instead, it manages them through a structured Annex system, categorized by function and
purpose.
Annex II : Prohibited Substances
Annex III : Restricted Substances
Annex IV : Permitted Colorants
Annex V : Permitted Preservatives
Annex V I : Permitted UV Filters
In particular, colorants, preservatives, and UV filters may only be used if they are
explicitly listed and comply with defined conditions.
2. Continuous Updates to Ingredient
Restrictions
Ingredient regulations in the EU are not determined solely within the cosmetics
framework.
It is closely linked to the REACH Regulation, the EU’s overarching framework for
chemical management. When a substance is identified under REACH as an SVHC (Substance of
Very High Concern) or classified as a CMR (Carcinogenic, Mutagenic, or Reprotoxic
substance), it may subsequently be subject to restriction or prohibition under the EU
Cosmetics Regulation. Therefore, even ingredients that are currently permitted may
become regulated in the future, making continuous monitoring of regulatory developments
essential.
3. Fragrance, Documentation, and Marketing Are Also
Regulated
In the EU, fragrances are treated not merely as sensory elements but as substances to
which consumers are exposed. Certain fragrance allergens are subject to mandatory
labeling, and the scope of regulation continues to expand. Fragrance use must also
comply with the standards established by the International Fragrance Association (IFRA).
The IFRA Standards define maximum usage levels by product category, and in practice,
compliance with these standards is generally expected in the EU market in the EU market.
Accordingly, for products with higher fragrance content, it is essential to go beyond
formulation considerations and conduct a comprehensive pre-assessment, including
allergen labeling requirements and IFRA compliance.
In addition, rather than approving products, the EU requires companies to maintain a
Product Information File (PIF). This file—covering ingredient data, safety assessments,
test reports, and GMP-related documentation—must be readily accessible to competent
authorities upon request by competent authorities.
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point 3
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Q1. What should be prepared first
when placing products on the EU market ?
Clear, well-structured, and traceable documentation, along with defined
accountability, is essential. As the EU adopts a notification-based system
rather than pre-market approval, companies bear full responsibility for
product safety upon placing products on the market.
OTCM systematically manages Product Information Files (PIF) and safety
assessment data in full compliance with EU regulations, covering everything
from raw materials to finished products. In addition, OTCM’s administrative
support aligned with global standards enables efficient and accurate
handling of complex notification procedures.
How can companies respond to the
complexity and continuous updates of EU ingredient regulations?
Partnering with a company that has strong expertise in raw materials is
critical. The EU strictly manages ingredients by function through the Annex
system, and certain categories—such as UV filters—can only be used if they
are included in the permitted lists.
Leveraging the raw material expertise of Sunjin Beauty Science, OTCM
continuously monitors the latest regulatory developments, including REACH
and CMR classifications, to propose formulations that are both safe and
innovative. In addition, OTCM proactively reviews fragrance allergens and
IFRA guidelines to prevent potential delays in product launch caused by
ingredient-related issues.
Can marketing claims targeting
European consumers be used freely?
No, all marketing claims must be supported by scientific evidence. In the
EU, marketing claims are considered an integral part of compliance. OTCM
supports this from the product development stage by preparing objective data
and testing evidence to substantiate product efficacy. By enabling
evidence-based marketing strategies that avoid misleading consumers while
highlighting product strengths, OTCM helps build trusted brands across the
European market.
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The EU market is not simply a highly regulated environment, but one that systematically
evaluates product safety and compliance throughout the product lifecycle.
Ingredients are managed in a highly structured manner, continuously updated in alignment
with REACH, and regulatory requirements extend beyond formulation to include fragrance
allergens, Product Information File (PIF) documentation, and marketing claims. While
there is no pre-market approval system, full responsibility is assumed at the time of
placing the product on the market.
Therefore, success in placing products on the EU market lies not in simply navigating
regulatory procedures, but in strategically designing products from the earliest stages
of development.
In the next newsletter, we will outline the key practical requirements needed to
successfully prepare for entry into the EU market.
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