Informace o shodě produktů OntexCZ
September 13, 2022
PRODUCT SAFETY AT ONTEX
As manufacturer of hygiene products, Ontex sees quality and product safety as key-priorities. All raw materials are selected carefully in accordance with all applicable regulations on product safety. Furthermore, we want our products to be compliant with various other legal obligations, official recommendations, code of practices, voluntary commitments and state of the art toxicological considerations.
- GENERAL INFORMATION
We would like to emphasize that there are no indications, nor reports that today’s absorbent hygiene products trigger any significant adverse events. Customer and consumer complaints are continuously monitored and stored in a dedicated global complaint database.
Most of the complaints that are referring to skin symptoms (erythema, rash, white spots) are linked to moisture close to the skin. A few complaints refer to physical hazards (e.g. sharp edges).
Several studies from different authorities related to Absorbing Hygiene Products (AHPs) came to the same conclusion i.e. certain trace chemicals can be detected in AHPs, but always at very low and at safe concentrations, unlikely to cause any negative effects to the end-user: KEMI (S), 2018 / BLV (CH), 2018 / VITO (B), 2018 / BfR (D), 2019.
- RAW MATERIALS
Incontinence products are medical devices meant for prolonged direct skin contact according to ISO 10993-1. All other absorbing hygiene products Ontex is producing, are considered as consumer products in Europe. (Tampons are considered as Medical devices in some countries such as the US and Canada). At Ontex, we don’t make a distinction between different types of absorbing hygiene products related to raw material safety clearance.
Therefore, we need to obtain all required physical and chemical information. Gathering the physical information is part of the design and development process and will be integrated into the routine Quality inspection during production (e.g. metal detection, glass prevention, …)
For the chemical clearance, it is important to emphasize that all absorbing hygiene products are so-called complex articles composed of different articles and preparations according to REACH. The chemical characteristics of the different used raw materials will remain unchanged during production at Ontex. Therefore, our key focus is at the raw material side, to ensure biocompatibility and chemical safety.
- Requested information from the supplier
During the validation phase of new raw materials or in case of any changes to the raw material composition or their production processes, the following information will be requested to the supplier:
- The Safety Data Sheet (for preparations and substances)
- The Ontex conformity declaration
- The raw material composition
- Biocompatibility tests for raw materials meant for direct skin contact
- Trace chemical tests
The completed Ontex conformity declaration will be sent directly to an external toxicologist for screening and to make a first risk assessment of the provided information (see conformity declaration). In case of any doubts, the status of the conformity declaration will be ‘pending’ and additional clarifications / documentation will be requested.
If the toxicologist concludes that sufficient detailed information has been provided to ensure legal compliance and safety, the status of the conformity declaration will be put on ‘approved’. The Regulatory Affairs Department will monitor all information, based on the monthly report provided by the Toxicologist and take the necessary actions to solve the pending issues. They have the last word during this risk assessment.
Every three years, the quality department will ask the supplier to renew or reconfirm all information provided and the same process will restart.
- The Safety Data Sheet
Basic information that will be requested for all substances and preparations (limited number at Ontex).
- The Ontex Conformity declaration (Regulatory compliance and Ontex requirements)
A special conformity declaration has been developed by Ontex more than 15 years ago as part of the required raw material information. This conformity declaration is frequently updated to cover the newest expectations from all different stakeholder such as authorities (key focus Europe and US), customers, NGO’s, ... This conformity declaration is composed of 4 different segments:
- Legal requirements (REACH, BPR, US CPSIA, Cal.Prop. 65, Flammable Fabrics)
- Safety requirements (German code of evaluation for sanitary product, material in contact with food, perfume, INK, adhesives)
- Trace chemical management
- Important Information to complete our safety evaluation and answer different questions and concerns
All this information is stored in our SAP system and updated at least every three years.
- The raw material composition (intentionally added substances and known impurities)
The main chemical composition (intentionally added substances) of each raw material as well as the most common impurities, are requested as addendum to the conformity declaration since April 2020 under NDA.
This information will always need to be updated by the supplier and reconfirmed at least every three years. Based on this information an Exposure Based Risk Assessment can be made (EDANA EBRA methodology)
- Biocompatibility of raw materials
Each raw material with direct skin contact will need to be tested on biocompatibility. Basically, R&D will be requesting information on cytotoxicity, sensitisation and skin irritation. The preferred test methods are described on the conformity declaration.
These studies will need to be repeated whenever the chemical composition of a raw material changes and any negative impact can’t be fully excluded based on the change in formulation.
Every three years, the supplier has to reconfirm ‘conformity’ of the delivered information or send us some new test results.
Occasionally a reference sample can be tested to release a group of similar raw materials. In such case, a motivation letter will have to be sent to the Ontex Regulatory Affairs Department e.g. different dimensions, weight, printed materials (max. quantity of different possible inks to be applied), …
The Regulatory Affairs Team will evaluate the received information and approve or reject the results. All records will be stored centrally.
- Trace Chemical Tests
For each raw material, a chemical analysis needs to be performed since April 2020, focussing on the following chemicals:
- Heavy metals (Sb, As, Cr(IV), Pb, Hg, Ni, Cd)
- DCP / 3-MCPD
- Dioxins / Furans (PCDDs / PCDFs)
- Pesticides / herbicides
- Glyphosate / AMPA / Quintozene / Hexachlorobenzene
- NP / NPEO
- 26 known (cosmetic) allergens
- Nitromusk / Polycyclic musk compounds
- In case sufficient prove exists about the absence of a certain chemical, a rational can be provided
- The Edana methodology for testing finished products is the preferred test method for testing raw materials as well.
- LEACHABLE SUBSTANCES (ISO 10993-17 / ISO 10993-18)
The main chemical composition (intentionally added substances) of each raw material as well as the most common impurities, are requested as addendum to the conformity declaration since April 2020.
In case any suspected (Edana Codex) / unknown chemicals are present, the Edana EBRA (Exposure Based Risk Assessment) principles will be applied.
Edana and its members have been rolling out a complete stewardship programme for all types of absorbing hygiene products (AHPs = babydiapers, femcare products and incontinence products), which is fully supported by Ontex.
The purpose of the stewardship programme is to reassure consumers of the safety of all absorbent hygiene products by defining
- A list of substances of interest
- Limit values not to be exceeded
- Using harmonised consumer relevant test methods
- Strong cooperation within the supply chain and external stakeholders
The stewardship programme consists of a
- Stewardship Programme Charter
- Governance structure
- Stewardship Programme Codex
Ontex has signed the Charter, which is a formal commitment for participation in the development and implementation of the Edana stewardship programme. We commit to create the necessary transparency of the product composition on material components.
The Codex part is the core of the EDANA initiative and comprises of:
- The list of substances of interest, plus
- Industry agreed limit values for their presence
- Analytical test methods for assessing the levels in AHP’s
Additionally a nomenclature has been created to identify the different raw materials present in absorbent hygiene products to enable uniform labelling of the different used components.
- BIOCOMPATIBILITY OF FINISHED PRODUCTS
A product can be assembled in multiple ways, using different approved raw materials. To deal with the complexity of our products and the numerous possible combinations, the main focus will be on the biocompatibility of the raw materials, especially those in close contact with the human skin.
Biocompatibility studies will be performed on finished products, in case of any new released product concepts. The studies performed are Cytotoxicity, Sensitisation and Skin irritation.
This clinical investigation will be launched by R&D and evaluated by the R&D and Regulatory Affairs Team. The Regulatory Affairs Team will approve / reject the results and store these centrally.
- POST-MARKETING / VIGILANCE
Post-marketing surveillance and vigilance activities such as complaint investigations, test results, published articles, scientific studies, improved industry standards, new regulations, and voluntary standards … can result in additional testing and / or re-evaluation of existing data whenever appropriate.
- MEMBERSHIP EDANA AND COMPLIANCE WITH THE EDANA SUPPLY CHAIN INFORMATION FOR ABSORBENT HYGIENE PRODUCTS
Ontex is an active member of EDANA over 25 years and participates in different Steering Committees and Working Groups. Ontex has a.o. been actively participating in the development of the Edana Supply Chain Information for AHP’s document. Ontex is continuously evaluating its product safety approach and regular updates are launched.
Group Sustainability & Regulatory Affairs Director
Ontex BV – Aalst Office