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Technical Regulations forBiodegradable Plastic Products

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Article (I)

Definitions

In applying the provisions of this Resolution, the following terms shall have the meanings ascribed thereto, unless the context indicates otherwise:

The “Ministry”: Ministry of Industry, Trade and Tourism

The “Council”: Supreme Council for Environment.

The “Competent Department”:

Directorate of Environmental Control and Assessment of the Supreme Council for Environment.

The “National Standard”:

A nation-wide approved document that sets out, for normal and repeated use, the rules, including the instructions and characteristics of the products, processes and the relevant methods of production to which commitment may not be mandatory, in particular the terminologies, definitions, packaging, marking or labeling requirements applicable to products, services, processes or methods of production.

The “National Technical Regulations”:

A nation-wide approved document that sets out the characteristics of the products, their associated processes and methods of production, including the applicable administrative provisions to be committed to. It may include or specifically consider the terminologies, definitions, packaging, marking or labeling requirements applicable to products, services, processes or methods of production.

The “Label”: A verifiable plastic label owned by the Council, which is placed on the products in accordance with the requirements of this Regulation to indicate conformity of the product to thereto, which shall be in the form specified in Annex XI.

The “Accredited Laboratory”:

The test, inspection or calibration laboratory that has been granted accreditation according to the ISO17025 by a recognized accreditation authority in the field of biodegradable plastic tests.

Market Survey: Activities and measures taken by Market Survey Authorities to verify that products meet the requirements of the relevant Gulf Technical Regulations and do not constitute a hazard to health, safety and the environment or any other aspect related to the protection of public interest.

Test Report: A document issued by an accredited laboratory, provided that it has not been issued for more than one year upon submission of the license application.

Conformity Assessment Procedures:

Procedures for proving that specific requirements for a toy, process, system, person or entity have been met.

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The “Economic Operator”:

Manufacturer, official representative, importer and distributor.

The “Manufacturer”:

Any natural or legal person manufacturing a plastic product, assigns its design or manufacturing to another natural or legal person, and then markets it under its own name or under its own brand.

The “Product”: Plastic products made of polypropylene and polyethylene plastic.

Biodegradable Plastic:

Water, carbon dioxide and the biomass are resulted from its decomposition caused by naturally-occurring microorganisms.

Biodegradable Plastic by Oxidation:

Plastic that degrades when exposed to environmental conditions to produce low (fragmented) molecular weight, and can be classified according to the time it is exposed to, according to the appropriate standard test method.

The “Type”: A set of variations of the product, the differences between which do not affect the level of safety or the other performance requirements.

Accreditation of the Type:

A conformity assessment procedure, whereby the Notified Body reviews the technical design of the product, verify its validity and acknowledges that the technical design of the product complies with the requirements of the relevant National Technical Regulations.

Technical Documents:

Documents specified in Annex (III) of this Regulation.

The “Notified Body”:

The Applicant Body that has been designated as a conformity verification body that is able of performing the conformity verification procedures in accordance with a certain scope, which are provided for in the Technical Regulations, which is usually an accredited body.

Article (II)

Field of Application

This Resolution shall be applied to all products made of polypropylene and polyethylene, provided for in Annex (I), which are often used for short periods and then get disposed of, in accordance with the Standard Specifications contained in Annex (II). This Regulation requires that the products covered shall be biodegradable, excluding plastic products used in the medical and food industries.

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Article (III)

Objective

The purpose of the Regulations is to regulate and govern the use of plastic products by defining their environmental requirements for the sake of preservation of environment, health and safety in different areas and to facilitate the procedures of market survey, noting that fulfilling the requirements of this Regulation shall not preclude compliance with the requirements of technical regulations related to the safety of the product in question.

Article (IV)

License Requirements for Labeling

The Supreme Council for Environment shall grant the license to label the product when the following requirements are met:

1. Submission of an independent application for each of the products specified in Annex I.

2. Attachment of a valid Commercial Registration Certificate containing the name of the activity specified by the concerned authority for performance of the production or import activity.

3. Fulfillment of the requirements of the Regulation and the Conformity Assessment Procedures thereof as described in Annex III.

4. Attachment of the ISO 14001 Certificate of the manufacturer. 5. Attachment of the Undertaking Form of conformity as described in the Annex

IV. 6. Attachment of the technical test reports from an accredited laboratory

covering all aspects specified in the Annex V, in addition to a copy of the valid certificate of accreditation of the laboratory.

7. Attachment of the technical documentation of the product, which include a general description of the product in addition to the design artworks, component parts and place for the label and the name of the manufacturer.

8. Provision of a description of the raw materials used in manufacturing of the product.

9. Provision of a proof that additives or substances involved in the production process –for food-contacting products– are safe for food (do not affect food safety) in accordance with the relevant national standards.

10. Provision of statistical data on production quantities of the local manufacturer of all plastic products for the previous year.

11. Provision of any other information or samples of the product at the expense of the Economic Operator to be determined by the Competent Department so as to verify that they meet the requirements of this Regulation.

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Article (V)

Product License

1. The Competent Department shall issue a renewable annual license for importing and manufacturing of the plastic products covered by this Regulation. No person or entity shall trade the said product without obtaining this License.

2. The Competent Department shall issue an official letter explaining the reasons for rejecting licensing of the product after receiving all the required documents and data. The license applicant shall complete all the corrections, documents and data required within five (5) business days of receipt of the said letter, otherwise the application shall be deemed repealed.

3. The applicant may apply for renewal of the License at least one month before the expiry date thereof.

4. The Competent Department shall be entitled to request samples of the products or to collect samples from the local market, randomly or whenever necessary, for the purpose of conducting a laboratory analysis of conformity so as to ensure that the product meets the requirements of this Regulation and relevant specifications.

5. The Competent Department shall have the right to take legal actions in the event that the results of the analysis of the product samples are proved to be inconsistent with the limits of the License granted, and the Economic Operator shall bear the entire cost of the tests in this case.

Article (VI)

Responsibility of the Economic Operator

1. The Economic Operator shall bear full legal responsibility of implementation of the requirements of this Regulation.

2. The label may only be used for licensed plastic products that have met the Conformity Assessment Procedures. Otherwise, the Competent Department may take all legal actions in case of otherwise proven by physical evidence.

3. The product labeling shall comply with the requirements of this Regulation and the relevant standards, including the following information:

• Name or brand of the manufacturer. • Country of origin. • Production date (day, month and year) and the barcode. • Validity period. • Storage conditions. • Purpose of use. • The label indicating that the product is "biodegradable". • Number of the License issued by the Council for production and

marketing of the product.

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Article (VII)

Labeling Requirements

Following obtaining the written approval from the Competent Department, the manufacturer may label the product as described in Annex VI in accordance with the following requirements and controls:

1. The label shall cover 10 - 15% of the total space of the product. 2. The printing shall be very clear and difficult to remove. 3. The colors specified in the label shall be complied with. 4. The label shall not overlap with the rest of the images and phrases on the

product. 5. The label shall be placed on each piece, alongside observance of the sizes,

and the Competent Department may allow placement of the label on the packaging.

Article (VIII)

General Provisions

1. The Economic Operator shall comply with all other regulations and bylaws in force in the Kingdom of Bahrain that are relevant to environment, security and safety

2. The Economic Operator subject to the provisions of this Regulation shall cooperate with the supervisory authorities and the market survey authorities and provide all the facilities and information required thereby to carry out the tasks entrusted thereto.

3. The Competent Department may consider the technical regulations of other countries that are equivalent to the National Technical Regulations in case they are found to be sufficiently fulfilling the objectives of this Technical Regulation.

4. All plastic products factories in the Kingdom of Bahrain are subject to the Environment Impact Assessment process to ensure that they meet the licensing requirements of the facility and the requirements specified in this Regulation.

5. This Resolution shall not include locally-produced plastic products intended for the external market use.

6. The Economic Operator which obtains a License from the Competent Department may use the label on the licensed products and advertise the same in various media and commercial means.

7. In case of any modifications made to the product during the License period, with the exception of form-related modifications such as color, the License shall become repealed for the product in question, and a new application shall be submitted for obtaining a License.

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Annex (I)

List of the polypropylene and polyethylene plastic products covered by this Regulation

No. Name of the Product Customs Code

1 Carrier Bags 39211300

2 Courier and Security Bags 39211300

3 Mail Order Bags (Magazine and Newspaper Bags) 39211300

4 Soil Remediation, Agricultural/Horticultural Application (e.g. Banana Bags, Mulch Film)

39269069

5 Bubble Wrap and Cushioning Packaging 39211200 39211100 39202000 39219000

6 Flower Wrap 39211200 39211100 39202000 39219000

7 Overwrap 39211200 39211100 39202000 39219000

8 Stretch Film 39211300

9 Cling Film 39211300

10 Plastic Liners for Carton 63063000

11 Polyethylene Sheets on Rolls, such as Table Covers 39211900 39232100

12 Personal Care products such as Gloves, Shoe Covers, Aprons and Disposable Personal Care Products

39262090 39269099 63079040

13 Bags for Packaging Bread, Nuts, Sweets ad all Bakery Items 39232100

14 Plastic Bags for Seedlings 39232100

15 Shrink Film 39232100

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16 All disposable plastic bags used for one time only, including shopping bags, garbage bags and garment bags. At a later stage, disposable eating tools such as pots, spoons and cups.

39151000 39173210 39241090 39232100 39241039

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Annex (II)

List of Approved Standards

No. Standard Title of Standard 1 SASO 2879 Degradable Plastic Products.

2 SASO ISO 14851:2009 Determination of the Ultimate Aerobic Biodegradability of Plastic Materials in an Aqueous Medium – Method by Measuring the Oxygen Demand in a Closed Respirometer.

3 SASO ISO 14852:2009 Determination of the Ultimate Aerobic Biodegradability of Plastic Materials in an Aqueous Medium – Method By Analysis of Evolved Carbon Dioxide.

4 SASO ISO 14855-1:2014

Estimation of the Ultimate Aerobic Biodegradability of Plastic Materials under Controlled Composting Conditions – Method by Analysis of Evolved Carbon Dioxide – Part I: General Method.

5 SASO ISO 14855-2:2014

Estimation of the Ultimate Aerobic Biodegradability of Plastic Materials under Fertilizer Degradation Conditions – Carbon Dioxide Development Method, Part 2 – Carbon Dioxide Gravity Monitoring Measurement in the Laboratory – Range Test.

6 SASO ISO 17556:2014 Plastics – Estimation of the Ultimate Aerobic Biodegradability of Plastic Materials in Soil by Measuring the Oxygen Demand in a Respirometer or the Amount of Emitted Evolved Carbon Dioxide.

7 ASTM D 6954 Standard Guide for Exposing and Testing Plastics that Degrade in the Environment by a Combination of Oxidation and Biodegradation.

8 CEN/TR 15351 Plastics – Guide for the Vocabulary in the Field of Biodegradable Plastic

9 SASO/ISO 472/2006 Plastic – Vocabulary

10 SASO GSO 1863 Food Packages – Part 2: Plastic Package – General Requirements

11 SASO ASTM D6988 Standard Guide for Determination of Thickness of Plastic Film Test Specimens

12 SASO ASTM D5208-14 Standard Practice for Fluorescent Ultraviolet (UV) Exposure of Photodegradable Plastics

13 SASO ASTM D3826-98:2013

Standard Practice for Determining the Degradation End Point in the Degradation of Polyethylene and Polypropylene Using a Tensile Test

14 SASO ASTM D4001 Standard Test Method for Determination of Weight-Average Molecular Weight of Polymers

15 SASO ASTM D2765-11 Standard Test Methods for Determination of Gel Content and Swell Ratio of Cross-linked Ethylene Plastics

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16 SASO ASTM D5988-12 Standard Method for Determining Aerobic Biodegradation of Plastic Materials in Soil.

17 ASTM D 6954 Vocabulary of Plastics

18 BS 8472:2011 Methods for the Assessment of the Oxo-Biodegradation of Plastics and assessment of the Phyto-Toxicity of the Residues in Controlled Laboratory Conditions

19 SASO ISO 17556:2012 Plastics – Determination of the Ultimate Aerobic Biodegradation of Plastic Materials in Soil by Measuring Oxygen Demand in Measuring Respiration or the Amount of Emitted Carbon Dioxide

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Annex (III)

Type of Conformity Assessment (Type 1a) in accordance with the ISO/IEC 17067

Type Approval

1. Methods of type approval: The type shall be approved based on one of two methods below: a. Examining a typical sample of the entire product, so that it represents the

expected production (production model). b. Assessment of the conformity of the technical design of the product by

reviewing the technical documents and evidence (design model), along with examining a representative sample of the planned production for one or more of the risk-related parts of the product (combining the production model and the design model).

2. Procedures of type approval: The manufacturer shall submit an application for approval of the type at a Notified Body of its own choice, provided that the application shall contain the following: a. Name and address of the manufacturer. b. A written declaration after submission of the same application to any other

Notified Body. c. Technical documents that enable the assessment of conformity of the

product to the requirements of the National Technical Regulations, and to contain an appropriate risk analysis and assessment.

d. The technical documents shall specify the requirements applicable to the product, provided that they shall include - as required by the assessment - the design, manufacture and operation (use) of the product.

e. The technical documents shall include at least the following elements: 1. General description of the product. 2. Design drawings, manufacturing and graphs of the elements, units,

components, etc. 3. Descriptions and clarifications necessary for understanding the

aforementioned drawings, graphs and operation (use) of the product. 4. A list of National Standards or any other appropriate technical

standards approved by the Competent Department, whether applied in whole or in part, and a description of the solutions adopted to meet the basic requirements of the National Technical Regulations, in the event that the said standards are not applied. In the case of partial use of National Standards, the applicable provisions shall be provided for in the technical documents.

5. Results of reports (graphic calculations) of the design, observations and tests carried out, etc.

6. Test reports. 7. Samples representative of the planned production and the Notified

Body may request further samples, if necessary.

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8. Evidence (proofs) supporting the appropriateness of technical solutions in design, where such evidence shall refer to all applied documents, particularly in case the relevant national standards and/or technical standards are not applied, and the supporting evidence shall include, whenever necessary, the results of the tests carried out in the appropriate laboratory at the manufacturer or in a laboratory under its own responsibility.

3. Tasks of the Notified Body a. For the Product: Studying the technical documents and supporting

evidence (proofs) in order to assess the suitability of the technical design to the product.

b. For Samples: Carrying out the following: 1. Ensuring that manufacturing of samples conforms to the technical

documents and identifying the elements designed according to national standards and the elements designed according to other standards.

2. Conducting appropriate tests and examinations, or authorizing who will perform them, in order to ensure that the technical solutions followed by the manufacturer meet the main requirements specified in the standard in case the relevant standards are not applied.

3. Conducting the appropriate tests, or authorizing who will perform them, in order to ensure that, in the case of non-application of the national standards and/or other appropriate standards, the technical solutions followed by the manufacturer meet the basic requirements of National Technical Regulations.

4. Agreeing on the place of conducting the tests with the manufacturer. c. For the Decisions of the Notified Body:

1. The Notified Body shall issue an assessment report on the procedures taken thereby and the outputs thereof. The Notified Body shall not publish this report in whole or in part unless after the approval of the manufacturer.

2. In case the type complies with the requirements of the National Technical Regulations applicable to the product in question, the Notified Body shall issue a Type Approval Certificate for the manufacturer. The said Certificate shall contain the name and address of the manufacturer, the results of the tests, conditions of their validity, if any, and the information needed to identify the approved type. The Certificate may also contain annexes.

3. The Certificate and its annexes shall contain all appropriate information for assessment of the conformity of the manufactured products according to the tested type and for monitoring during operation.

4. In case the type is not in conformity with the requirements of the National Technical Regulations applicable to the product in question, the Notified Body shall not issue the Type Approval Certificate, and shall notify the applicant with its decision, alongside providing the same with the detailed reasons for not issuing the Type Approval Certificate.

5. The Notified Body shall follow up all the recognized technical developments. Whenever such developments indicate that the approved type may not conform to the requirements of the National

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Technical Regulations, the Notified Body shall determine the need for conducting further testing and shall notify the manufacturer accordingly.

6. The manufacturer shall notify the Notified Body, which keeps the technical documents for type certification, with all the changes made in the approved type, which would affect the conformity of the product to the requirements of the National Technical Regulations or the requirements of validity of the type in question, since such changes require additional approval on the preliminary Type Approval Certificate.

7. Each Notified Body shall inform the Council of the Type Approval Certificates or any addition issued or cancelled, and shall periodically provide, or upon request, a list of the Type Approval Certificates and any additions that have been rejected or the ones that have been suspended or restricted in any form.

8. Each Notified Body shall notify the other Notified Bodies of the Type Approval Certificates and any additions that have been rejected or the ones that have been suspended or restricted in any form, and shall also report, upon request, on the Type Approval Certificates or any additions made thereto.

9. Upon request, the Competent Department or the Notified Bodies may obtain copies of the Type Approval Certificates and/or the additions thereto. The Council may, upon request, obtain copies of the technical documents and the results of the tests carried out by the Notified Body. The Notified Body shall keep a copy of the Type Approval Certificate, and the annexes and additions thereto, as well as the technical documents, including the documents annexed by the manufacturer, until the expiry date of the Certificate.

10. The manufacturer shall keep a copy of the Type Approval Certificate, and the annexes and additions thereto, alongside the technical documents, and make the same available to the regulatory authorities and market survey authorities for ten years after placing the product in the market.

11. The supplier may submit the request specified in Clause (2) above and perform the aforementioned tasks on behalf of the manufacturer, provided that this shall be carried out in accordance with the consent of the manufacturer.

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Annex (IV)

Form of the Supplier's Compliance Declaration

This form shall be filled out using the Company's official paper

Supplier's Compliance Declaration

1) Supplier's Data a. Name: b. Address: c. Contact Person: d. E-mail: e. Telephone Number:

2) Product Details a. Brand of the Product b. Type c. Product Description d. Reference Standards/Technical Standards

We acknowledge that the product specified in this declaration is a product conforming to the Ministerial Resolution No. XXXXXXXXXX of year XXXXXXXX concerning _________________________ and the Implementing Regulations thereto.

Person in Charge:

Signature:

Company Seal:

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Annex (V)

Writing of the Test Reports

The report shall specify the following:

1. A Clear use of the product, and the purpose of application. 2. Indication of the product specification (properties) including thickness. 3. Polymer type. 4. Mentioning of storage conditions required for the plastic to maintain the

properties, and not to commence biodegradation as well as the shelf period in a very clear manner.

5. Information on shipment tracking and shipping and transport conditions, including the required humidity level and temperature.

6. Indication of the expected length of service and storage time. 7. Recording exposure conditions such as temperature, time, humidity and

oxygen. 8. Recording exposure conditions and time (kJ/m 2. nano at 340nm) for

radiation, when used. 9. Determination of the molecular weight, tensile elongation and percentage of

gels in the samples before and after the indicated time for exposure to abiotic test.

10. Writing the sample mass before and after the test. 11. Measurement of the extent of biodegradation, expressed as a percentage of

theoretical carbon dioxide. 12. Identifying the percentage of gel or other non-biodegradable ingredients. 13. Determination of volatiles produced by the process of oxidation (carbon

dioxide). 14. Declaration of the metal concentrations in accordance with Clause 4/1/5 of

SASO 2879. 15. Type of recycled materials used in the final product, if any, and their quantity

and source.

Note: Additives can have a very high impact on the performance of a biodegradable and oxidized additives system. Stabilizers such as antioxidants or UV absorbers can slow down the degradation of response, while certain types of dyes can accelerate degradation.

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Table No. (I)

Item Mg/Kg of Dry Material

Item Mg/Kg of Dry Material

Zinc 150 Chrome 50

Copper 50 Molybdenum 1

Nickel 25 Selenium 0.75

Cadmium 0.5 Arsenic 5

Lead 5 Fluorine 100

Test Report Form

Report on material test to Bahrain standard Date of Report Date of Reporting

Issuance

Name of the Manufacturer and/or the Trademark

Test Laboratory

Sample Submitting Entity: 1. Target Application. 2. Plastic Type. 3. Production Date. 4. Shelf Period.

No. of Testing Report Pages.

Sample Masses (MG) Sample Sizes (MM)

Tested Abiotic Degradation Test Test Used Result Reference Standard

Exposure Cycle A) and Total Exposure Time Lamp UV Used, Humidity/Temperature

1. M.wt 2. Elongation and Strength. 3. Gel Content

Biotic Test Biotic Test Report Attached. Plant – Toxicity Plant – Toxicity Test, Report Attached

According to 5/6 od SASO Metal Concentration Metal Test Report Attached According to

5/1/4 of SASO 2879. Product Fit its Standard The test Report Attached as per Each

Product Standard Reporting Requirement.

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Annex (VI)

Form of the Approved Label