SERVICES
- EU Responsible Person Service
- PIF Preparation
- CPNP Notification
EU Responsible Person Service
EU RP-Responsible Person based on the EU Regulation 1223/2009
EU Regulation 1223/2009, which went into effect July 2013, mandates that all products being sold in the European Union must comply with this regulation. Products must be represented by a legally qualified entity called a “Responsible Person.”
Let us be your EU RP-Responsible Person!
Our RP service provides the required notification, compliance and regulatory services to place and keep your existing cosmetic products in the 28 European countries. Our European location, as required, holds the Product Information File and Safety Assessment and is the address for product labeling.
ELNES as an EU RP-Responsible Person:
- Is able to respond to all technical issues of products and ingredients
- Understands Safety Assessment and technical criteria under the EU Regulation
- Avoids creating additional concerns from authorities when audited, protecting confidentiality
- Is responsible for chemical compliance
- Assures that all details on product labeling are correct, including individual countries’ language requirements
CPNP Notification
Europe (28 EU Member States) require compliance to 1223/2009 EU Cosmetic Regulation. This is the last step that confirms compliance and provides electronic proof to each EU Member government authority. Don’t get caught with a CPNP registration without proof of Product Information File (PIF) by a Qualified Responsible Person (EU RP), or conversely no PIF and no CPNP.
PIF Preparation
COSMETİC PRODUCT SAFETY REPORT PREPARATION
CPSR PART A
Cosmetic Product Safety Report: Documents required, test reports and statements
DOCUMENTS REQUIRED:
- Quantitative/Qualitative composition
- Artwork of the label
- Packaging chemical/physical data/ranges
- TDS (Technical data sheets) Material Safety Data sheets (MSDS) for raw materials
- Documents about Parfum/Fragrance used
- Manufacturing method description (work flow)
TEST REPORTS:
- Stability lab trial report/data
- Compatibility with the packaging
- Microbiological data/analysis/certificate
- Challenge test (to verify the efficacy of the preservative system)
- Claim substantiation tests/data
STATEMENTS:
- Statement on Manufacturing Process (GMP / ISO 22716 if available)
- Statement on nanomaterials
- Statement on «no animal testing»
- Statement on batch attribution (traceability procedure)
- Statement on CMR substances (Cancerogenic, Mutagenic,toxic for Reproduction substances)
CPSR PART B
Cosmetic Product Safety Report: Safety Assessor and the Role of the Safety Assessor
SIGNED BY THE SAFETY ASSESSOR
Safety Assessor
A person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State Should be independent from the manufacturing and marketing
Role of the Safety Assessor
The Safety Assessor should work closely together with the Responsible Person to ensure that the safety of the product is properly assessed and documented and that the assessment is kept up to date Thus, the Responsible Person is in charge for all scientific and technical aspects through the appointment of qualified Safety Assessor, which will fully support the Responsible Person for issues relating to scientific and technical part