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The Importance Of Plastic Cosmetic Bottles Safety
Posted On 05/12/2021 07:54:17 by jinfu321

People are increasingly demanding when buying new products.

When we talk about the safety of cosmetic packaging, we must bear in mind the current legislation. In this regard, within Europe, we have the regulation 1223/2009 on cosmetics. According to Annex I of the Regulation, the "Cosmetics Safety Report" must include detailed information about impurities, traces, and information about packaging materials, including the purity of the substance and mixture, the evidence that its technology is unavoidable in the presence of prohibited substances, and Relevant characteristics of packaging materials, especially purity and stability.


Other legislation includes Decision 2013/674/EU, which establishes guidelines to make it easier for companies to meet the requirements of Annex I of Regulation (EC) No. 1223/2009. The decision specifies the information that should be collected on packaging materials and the potential migration of substances from packaging to cosmetics.

In June 2019, European Cosmetics issued a non-legally binding document, the purpose of which is to support and promote the assessment of the impact of packaging on product safety when Plastic Cosmetic Bottles are in direct contact with packaging.

Packaging directly in contact with cosmetics is called primary packaging. Therefore, the characteristics of the materials in direct contact with cosmetics are important in terms of cosmetic safety. Information about the characteristics of these packaging materials should be able to estimate any potential risks. Relevant characteristics can include the composition of packaging materials, including technical substances such as additives, and technically unavoidable impurities or substances that migrate out of the packaging. Therefore, the safety of Plastic Cosmetic Bottles is very important. Just like Beverage Bottle, they have to go through many tests before they can reach the standard.

Since the biggest concern is the possible migration of substances from packaging to cosmetics, and there are no standard procedures available in this area, one of the most widely established and accepted methods in the industry is based on verifying compliance with food contact regulations.

The materials used to make cosmetic packaging include plastics, adhesives, metals, alloys, paper, cardboard, printing inks, varnishes, rubber, silicone, glass and ceramics. According to the regulatory framework for food contact, these materials and articles are subject to regulation 1935/2004 (known as the framework regulation). These materials and articles should also be manufactured in accordance with Good Manufacturing Practices (GMP) in accordance with quality assurance, quality control and documentation systems. This requirement is described in Regulation 2023/2006 (5). The Framework Regulation also provides for the possibility of establishing specific measures for each material to ensure compliance with established basic principles. The material used for the most specific measures covered by Regulation 10/2011(6) and subsequent amendments is plastic.

Regulation 10/2011 sets out requirements for raw materials and finished products. The information to be included in the declaration of conformity is listed in Annex IV (this annex is supplemented by the "Alliance Guidelines" on information in the supply chain. The "Alliance Guidelines" are designed to provide key information to convey the requirements for compliance with the Regulations. 10/2011 in the information supply chain). Regulation No. 10/2011 also stipulates quantitative restrictions on substances that may be present in the final product or can be released into the food (migration), and stipulates the standard of testing and migration test results (requirements of the final product).

In terms of laboratory analysis, to verify compliance with the specific migration restrictions specified in the regulations 10/2011, the laboratory steps that should be taken include:

1. The packaging manufacturer must have a Declaration of Conformity (DoC) for all plastic raw materials used in accordance with Annex IV of the Regulation 10/2011. This supporting document enables the user to check whether a material has been formulated for contact with food, that is, whether all substances used in the formulation are listed in Annex I and II of Regulation 10/2011 and subsequent amendments (reasonable exceptions) except).

2. Conduct an overall migration test to verify the inertness of the material (if applicable). During the entire migration process, the total amount of non-volatile substances that can migrate into the food can be quantified without determining individual substances. The overall migration test is carried out in accordance with the standard UNE EN-1186. These tests with simulants will change the number and form of contact (such as immersion, single-sided contact, filling), and the total migration limit is 10 mg/dm2 of contact surface area. For plastic materials in contact with breastfed infants and young children, the limit of food simulants shall not exceed 60 mg/kg.

3. If necessary, carry out quantitative tests on the residual content and/or specific migration to verify compliance with the limits specified in the legislation for each substance.

According to the UNE-CEN/TS 13130 ​​standard series for specific migration tests, as well as internal test procedures developed in the laboratory for chromatographic analysis. Of all the permitted substances, only some have restrictions and/or specifications. The standards with specifications must be listed in the DoC to verify compliance with the corresponding restrictions in the material or final product. The unit used to express the result of the residual content is mg of substance per kilogram of the final product, and the unit used to express the specific migration result is the number of milligrams of substance per kilogram of the simulant.

To design overall and specific migration tests, simulants and exposure conditions must be selected.

• Simulants: According to the food/cosmetics that can come into contact with the material, the simulants are selected according to the instructions contained in Annex III of Regulation 10/2011.


When conducting migration tests on cosmetic packaging, the simulant to be selected must be considered. Cosmetics are usually chemically inert water/oil based mixtures with a neutral or weakly acidic pH. For most cosmetic preparations, the physical and chemical properties related to migration correspond to the properties of the above-mentioned foods. Therefore, food-like methods can be used. However, certain alkaline preparations (such as hair care products) cannot be represented by the above-mentioned simulants.
• Exposure conditions:

To choose exposure conditions, the contact time and temperature between the packaging and the food/cosmetics in the packaging should be considered until the expiration date. This ensures that the test conditions that represent the worst foreseeable conditions in actual use are selected. The conditions for the overall migration and the specific migration are selected separately. Sometimes they are the same, but they are described in different chapters of the regulation 10/2011.

The most common test conditions in cosmetic packaging are:

Compliance with packaging regulations (after confirming all applicable restrictions) must be specified in the relevant DoC, which must include information about the use that can safely bring the material or article into contact with food/cosmetics (for example, type of food, time of use, and temperature) ). Then, the cosmetic safety consultant evaluates the DoC.

Plastic packaging designed to be used with cosmetics is not obligated to comply with regulations 10/2011, but the most practical option may be to adopt a method of use with food and assume that the raw materials must be suitable for contact with food during the packaging design process. Only when all agents in the supply chain comply with legal requirements can it be possible to guarantee the safety of packaged products.

Tags: Plastic Cosmetic Bottles



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