The Biweekly Pulse: 11th – 25th July – Saudi Arabia RoHS and Packaging Updates
The Pulse was originally posted on 30th July, 2025. Further regulatory developments may have occurred after publication. To keep up-to-date with the latest compliance news, sign up to our newsletter.
Check out the latest 2025 Regulatory Compliance Updates with The Pulse, your biweekly source for global regulatory insights!
This Week’s Trending Sources in C2P
- Global Packaging EPR Reporting Requirements: A Practical Comparison Guide, Whitepaper, July 2025
- Chemicals Quarterly – Q2 Regulatory Update, Webinar Presentation, July 2025
- UK: Restriction of Hazardous Substances (RoHS) Regulations, Guidance Document, Revised, July 2025
What is Our Content Team Talking About?
Saudi Arabia RoHS Recast Underway: Regulation to Clarify Obligations, Refer to Risk Assessment Method and Restrict Phthalates
by Joyce Costello, Senior Regulatory Compliance Specialist
Saudi Arabia’s Standards, Metrology and Quality Organization (SASO) has duly notified the WTO of a draft Technical Regulation that would recast the existing national RoHS measure by aligning provisions with the recently issued Product Safety Law, clarifying the economic operator’s obligations and adding four phthalates to the restricted substances, among other changes.
This draft technical regulation comes within the context of the Kingdom’s ongoing efforts to regulate technical aspects related to product safety, by regulating specific requirements that achieve the condition of non-discrimination between local and imported products.
Interested parties will see in this proposal new references to and definitions for ‘economic operators’: the manufacturer, the authorized representative, the importer, and the distributor. The concept of risk assessment would be defined as the process of identifying any hazard posed by a product and the steps that must be taken to prevent, eliminate, reduce, or control that hazard.
The scope definition would be more closely aligned with Annex I EU RoHS, listing the same product categories including the open scope, with the exception of medical devices, which remain excluded under Saudi RoHS.
Manufacturer Obligations
The new Regulation would provide a lengthy list of manufacturer obligations in Article (5), again corresponding more closely with EU RoHS obligations:
- Ensure that the design and manufacture of such products comply with the requirements set forth in these regulations and their appendices
- Conduct conformity assessment procedures as specified and provide the necessary evidence for this purpose
- Issue a manufacturer’s declaration of conformity in accordance with the conformity assessment procedure provisions
- Retain technical documentation and the manufacturer’s declaration of conformity for a period of ten (10) years after placing or offering the product on the market
- Ensure that the necessary procedures are implemented to ensure continued conformity for the serial production of the product, taking into account any change in the design or characteristics of the product in the Saudi specifications or other specifications on the basis of which the product’s conformity was declared
- Conduct tests on samples of marketed products, investigate complaints, and, where appropriate, maintain records of complaints regarding non-conforming products and resulting recalls, and inform distributors of these investigations
- Ensure that all products bear the model number, batch number, serial number, or other product identification
- Immediately take the necessary corrective measures to bring suspected non-compliant products into compliance, or recall or withdraw them, if necessary
- Ensure that the product is accompanied by safety instructions in Arabic, and instructions for use must be provided in Arabic
- Undertake to assess all product risks before placing them on the market and take the necessary measures to address, reduce, or eliminate them
Obligations of authorized representatives, importers and distributors in Articles 6, 7 and 8 respectively.
Products covered by this regulation will be deemed to meet the basic requirements if they are produced in accordance with the specifications related to the application of this regulation, provided that they do not conflict with the provisions of this regulation. The product’s conformity can be proved using other technical means or solutions that achieve the same required level of safety, provided that sufficient technical evidence is provided by the economic operator, and that the Authority approves the sufficiency of the evidence provided. The economic operator must adhere to national differences (national deviations) when applying any non-Saudi specification.
Risk Assessment Method
Each economic operator, according to their field and the obligations they entail, is obligated to conduct a systematic assessment of the risks associated with the products covered by these regulations, with the aim of preventing, eliminating, reducing, or controlling this risk. The results of this assessment must be documented in the technical file, and updated when any fundamental modification occurs to the product.
Conformity Assessment
Each economic operator responsible for placing the products on the market, according to their field and the obligations they entail, must implement conformity assessment procedures and obtain a supplier’s declaration of conformity, in accordance with the Type S conformity assessment form included in the General Regulations for Conformity Forms issued by SASO, ensuring that the product conforms to the basic requirements specified in Appendix (1) of this Regulation.
Technical File
The manufacturer must prepare a technical file in Arabic for each product. If this is not possible, a certified translation must be attached upon request, provided that the competent authorities approve it. The technical file must be retained for a period of no less than ten (10) years from the date the product was placed on the market.
The technical file must contain, at a minimum:
- Manufacturer’s declaration of conformity, in accordance with the form approved by the Authority
- Importer’s declaration of conformity, if necessary, in accordance with the form approved by the Authority
- The risk assessment document, in accordance with the guidance documents issued by the Authority
- General description of the product, conceptual design, manufacturing drawings and diagrams, and the explanations necessary to understand the content of those drawings and diagrams
- Result of the conformity assessment and any tests conducted by the manufacturer or another party on its behalf
- List of technical regulations and a list of specifications to meet the general safety requirements stipulated in the system
These regulations will be applied within a period not exceeding (180) days from the date of their publication in the Official Gazette, and a transitional period of 365 days will also run from the date of publication.
Certificates of conformity issued prior to the effective date will remain in effect until their expiry.
What Are Our Knowledge Partners Talking About?
Packaging EPR Shifts: California’s Single-PRO Model & Kenya’s Import Fee Implementation
by SagisEPR
USA / California – Packaging: Revised Draft Implementing Regulations Point to Long-Term Single-PRO Model
Revised draft implementing Regulations to SB54 signal a shift toward a single-PRO model, delay key deadlines to align with timelines in other US states, simplify PROs fees during the first 2 years, and revise the exclusions from the scope. California’s waste packaging regime continues to be slated for rollout in 2027.
Background: California’s 2022 Packaging Act (SB54) establishes an EPR-based waste packaging regime that:
- Covers single-use primary, secondary, and tertiary packaging, as well as plastic single-use food service ware;
- Permits only one PRO until 2031 [Note: Nonprofit PRO Circular Action Alliance (CAA) was approved in Jan-24 (news item)];
- Requires producers to join CAA, while allowing individual compliance under strict conditions;
- Mandates that the PRO fully reimburse municipalities for the costs of collection, transport, processing, sorting, public outreach, and infrastructure; and
- Sets binding targets for source reduction (25% by 2032), recyclability (all packaging by 2032), and plastic recycling rates (30%, 40% and 60% by 2028, 2030, and 2032 respectively).
The first draft of Regulations* to implement the Act was released in Dec-23. After CalRecycle failed to meet a 7-Mar-25 deadline to finalize the text, Governor Newsom ordered to restart of the drafting process, citing concerns that the regulations would impose unacceptable burdens on consumers and businesses.
* detailing the scope of covered materials and exclusions, recyclability and compostability criteria, producer registration, and requirements for PROs/individual compliers.
Revised Draft Regulations: On 16-May-25, revised draft implementing Regulations were released for public comment. Compared to the Dec-23 draft, the revised draft addresses industry concerns and incorporates recommendations by CAA. The key changes are as follows:
- The provisions and procedures on establishing and approving ‘additional PROs’ are removed (while the allowance is maintained in SB54), potentially shifting the regime toward a single-PRO model by default, unless future amendments to the Regulations revert this.
- The PRO registration and initial data reporting deadlines are postponed from 1-Jul-25 to 30 days after the entry into force of the regulations [Note: The separate 31-Aug-25 producer data reporting deadline set by CAA remains unchanged].
- Monthly reporting is replaced with annual reporting.
- CAA will be permitted to charge simplified, category-based fees in the first 2-years of the program, while also allowing eco-modulation incentives. Following that, the PRO must charge modulated fees.
- Covered costs (reimbursed by the PRO/individual producers to municipalities/treatment operators) may now be calculated using a performance-based method, such as reimbursement per tonne of covered material managed, rather than only by claims.
- Exclusions from the scope have been revised with regards to:
- reusable/refillable packaging and food service ware: Prior requirements for durability and washability have been replaced with criteria focused on return infrastructure and actual reuse/refill scenarios.
- packaging meeting certain recycling rate thresholds*: The 65% (pre-2027) and 70% (post 2027) recycling rate thresholds must now be met in each consecutive year, rather than averaged across any 3 consecutive years.
- materials ‘facing unique compliance challenges’: The default exemption period is extended from 1 to 2 years, with possible renewals and extensions up to 5 years.
- non-separable packaging components: A new de minimis exclusion allows producers to request CalRecycle designation for components that do not hinder recyclability, safety, or environmental performance.
- Provisions allowing PROs to adjust source reduction targets (due to economic/market changes) are removed, requiring performance against the targets to be measured using actual data.
Kenya – EPR: EPR Import Certificate Required for Imports Since 4-May-25
A 30-Apr-25 NEMA Notice calling on producers to apply for an EPR Import Certificate contains crucial information about how the KES 150 (EUR 1) fee per item will be applied. A 30-Apr-25 NEMA Notice on the implementation of the Nov-24 Sustainable Waste Management (EPR) Regulations* notably:
- Calls on producers to apply for an EPR Import Certificate required for all imports arriving from 4-May-25. The application should be made on NEMA’s eCitizen portal (allowing Kenya-based entities to apply and pay for NEMA services); and highlights the following EPR Regulations:
- Obligated producers** shall apply to NEMA for registration and issuance of EPR Certificate within six months of commencement of the Regulations.
- EPR import fee of KES 150 (EUR 1.02) per item will apply as follows**:
- Categories 1, 2 and 5: the import fee will apply to standard packaging. The standard packaging (the secondary/bulk packaging) will be indicated in the packaging list generated at the point of export and may include bales, cases, and pallets.
- Categories 3 and 4: fees will apply per product unit.
* The Nov-24 EPR Regulations created a framework for the establishment and operation of a mandatory EPR scheme. The Regulations cover a wide scope (see categories below), requires producer and PRO registration, and introduces an EPR import fee (as detailed above).
** Categories 1-5 are as follows:
- “Packaging for non-hazardous products (plastics, aluminum, composite, paper and its corrugates, glass, cardboard and carton).
- ‘Hazardous products’ packaging (industrial chemicals, oil and lubricants, pharmaceuticals, agrochemicals, veterinary, cosmetics, paints and solvents), treated wood and agricultural films.
- EEE, mercury auto switches, thermostats, battery and accumulators.
- End of life motor vehicles, automobiles, aircrafts, locomotives.
- Non packaging items (plastics, glass, paper, cardboard), furniture (except wooden, metallic), rubber and tires, textiles, leather, artificial hair, diapers and sanitary towels.”
What Are Our Clients Asking About?
Under the EU Packaging and Packaging Waste Regulation, is it Mandatory to Include the Test Reports of Heavy Metals Content in the DoC?
Answered by Rúan Doherty, Regulatory Compliance Analyst
Based on Article 39, and Annex VII, a test report on heavy metals content in packaging is required when completing the DoC as part of the conformity assessment.
Article 39 specifies that the DoC shall contain the elements set out in Annex VII. This annex outlines the overall conformity assessment procedure and includes the following elements:
- Technical documentation (including test reports);
- Details regarding internal production control, and manufacturing processes.
Annex VII, subsection 4, also details that the DoC shall be kept together with the technical documentation.
Therefore, the DoC shall contain details relating to technical documentation in order to demonstrate adherence to Articles 5 to 12 (i.e. test reports on heavy metals content).
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