Deraf EHS yang sedia ada sudah memadai dan harus diwartakan segera. Perkara ini adalah penting untuk Malaysia menjadi Parti kepada Stockholm dan Minamata Convention.

Roche Pharma Malaysia welcomes the opportunity to provide feedback to the Department of Environment (DOE) on the proposed regulations concerning Environmentally Hazardous Substances (EHS). We respectfully submit the following proposal/feedback for your consideration.

Feedback/Proposal
1. Exemption Alignment - Under the current draft, only radioactive substances, pesticides, chemical weapons, and substances regulated under the Poison Act 1952 are explicitly exempted. However, medical devices and in-vitro diagnostic (IVD) products undergo extensive evaluation by the Medical Device Authority (MDA) under the Medical Device Act 2012. Similarly, pharmaceutical formulations are rigorously assessed by the National Pharmaceutical Regulatory Agency (NPRA) under the Sales of Drugs Act 1952. We recommend that products governed under the Medical Device Act and Sales of Drug Act be included explicitly in the exemption list. This alignment is critical to safeguarding national health security and ensuring uninterrupted patient access to essential clinical diagnostic and therapies, effectively preventing administrative bottlenecks at ports of entry for time-sensitive, life-saving medical technologies and pharmaceutical products.

In addition, we also recommend an explicit carve-out be added to the "Non-application" or "Exemptions" Schedule of the draft regulation.
Recommended Legal Text to propose:
"These Regulations shall not apply to:
(a) finished products intended for the final user;
(b) pharmaceutical products and medicines regulated and registered under the Sale of Drugs Act 1952."

Thank you. Should you require any further clarification, please do not hesitate to contact us.

Persatuan Pengguna-Pengguna Pulau Pinang (Consumers’ Association of Penang) menyokong penggubalan Peraturan-Peraturan Kualiti Alam Sekeliling (Benda Berbahaya kepada Alam Sekeliling) 202X yang dirangka bagi menguruskan bahan berbahaya kepada alam sekeliling. Berikut adalah ulasan kami:
(i) Peraturan ini perlu nyatakan dengan jelas pengintegrasian aspek kesihatan awam. Ini termasuk kawalan terhadap bahan kimia pengganggu sistem endokrin (endocrine disrupting chemicals).
(ii) Pengeluar mesti memikul tanggungjawab kewangan sepenuhnya terhadap produk mereka serta kesannya sepanjang peringkat pengeluaran, penggunaan, dan pelupusan, di samping memastikan pengendalian sisa dengan selamat bagi menghapuskan pendedahan berkaitan EHS. Ini termasuk kos pembaikpulihan, remedi dan pampasan kepada pihak yang terjejas.
(iii) Maklumat dan data mengenai bahan kimia EHS Terjadual, termasuk data perdagangan, hendaklah tersedia untuk akses umum. Langkah ini akan memenuhi hak orang ramai untuk mendapatkan maklumat.
(iv) Peraturan mengenai bahan kimia yang berbahaya kepada alam sekitar hendaklah dilaksanakan secara berkumpulan. Sebagai contoh, bagi mengelakkan "penggantian yang merugikan" (regrettable substitutions), kumpulan bahan kimia bisfenol harus dipertimbangkan secara menyeluruh. Hal ini kerana apabila sesuatu bahan kimia seperti Bisfenol A (BPA) dilarang, pengeluar mungkin menggantikannya dengan bahan kimia serupa seperti Bisfenol S (BPS) yang membawa risiko kesihatan yang sama. Larangan terhadap kumpulan bahan kimia mesti diutamakan bagi menghentikan kitaran penggantian sebegini.
(v) Peraturan ini perlu mengandungi peruntukan bagi penubuhan Pollutant Release and Transfer Register (PRTR) pada masa hadapan, atau inventori nasional bagi benda berbahaya kepada alam sekeliling (EHS) dan bahan pencemar yang dibebaskan ke udara, air, dan tanah, mahupun yang dipindahkan ke luar untuk tujuan pengurusan sisa.
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Terjemahan
(i) The regulations must integrate public health aspects, including the control of endocrine-disrupting chemicals.
(ii) Producers must take full financial responsibility for their products and their impact through production, use, and disposal, and must ensure the safe handling of wastes to eliminate EHS exposures. This includes the costs of restoration, remedial measures, and compensation to the affected parties.
(iii) Information and data of the chemicals in the EHS schedule, including trade data, should be publicly available. This will fulfil the public’s right to know.
(iv) The regulation on environmentally hazardous chemicals should be done as groups of chemicals. For instance, to prevent "Regrettable Substitutions", bisphenols should be considered as a group of chemicals. This is because when one chemical such as Bisphenol A (BPA), is prohibited, manufacturers may replace it with a similar chemical such as Bisphenol S (BPS) that carries the same health risks. Restricting groups of chemicals must become the rule as it will stop this cycle of substitution.
(v) The regulation needs to include a clause for future establishment of Pollutant Release and Transfer Register (PRTR) or national inventory of environmentally hazardous substances (EHS) and pollutants released into the air, water, and soil, or transferred off-site for waste management.

Kindly refer to my comments in the file attached. Thank you.

Tidak dijelaskan apakah bahan-bahan yang terangkum di dalam Jadual Pertama, Jadual Kedua dan Jadual Ketiga. Elok sekiranya Jadual-Jadual ini dapat diperincikan. Terima kasih.